Recall Alert
| DRAP Alert No | No I/07-23-29 |
| Action Date | 27th July, 2023 |
| Target Audience | • Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. • People implanted with affected ICDs and CRT-Ds. • Procurement Officers at Hospitals and Healthcare Institutions. • Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue | Medtronic, USA received reports for their implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) for risk of patient harm as a result of low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature. The issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway. Accordingly, the manufacturing company is recalling all the defective product from the international market including Pakistan. |
Therapeutic Goods Affected:-
| Brand Names | Product Description | Lot No and Codes | Manufacturer and Distributor |
|---|---|---|---|
| o Cobalt XT, Cobalt, Crome ICDs and CRT-Ds o Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds o Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs | Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are intended to monitor and regulate heart rate and rhythm | Medical Device Recall Database Entries (FDA) (click to open) Distribution Dates: October 13, 2017 to June 9, 2023 | Medtronic USA Distributor in Pakistan: M/s Medtronic Pakistan (Pvt) Ltd. Karachi. |
| Risk Statement: | Defective ICDs, CRT-Ds poses a risk of patient harm as a result of low or no energy output when high voltage therapy is needed. Therefore, reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death. |
| Action Initiated | -The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed. -All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Medtronic issued an Urgent Medical Device Correction notice to customers. The communication provided the following required actions for software issue related to this recall: • Do not prophylactically replace devices for this issue. • Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue. • Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B. • Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming. • Remotely monitor patients following normal clinical protocol. Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: 1. Reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway) 2. A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |