MAUDE Adverse Event Report: ABBOTT QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event of the shape of the electrode being different than what was shown on the package was confirmed.As received, a complete lead was returned in one piece for analysis.Electrical testing did not reveal any indication of conductor fractures or internal shorts.Visual inspection of the lead revealed the proximal angle and the distal angle at the double bend region to be out of specification.The cause of the reported event was isolated to the as received condition of the lead.Abbott will continue to monitor and trend this issue and the performance of this product.

Event Description

This report is to advise of an event observed during analysis.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11631264
• MDR Text Key: 244368658
• Report Number: 2017865-2021-13989
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 1457Q/86
• Device Catalogue Number: 1457Q/86
• Device Lot Number: A000096754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1