MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During device replacement due to normal eri, the left ventricular (lv) lead was unable to be removed from the device header.The set screw was unable to be loosened.Upon lv lead removal attempt the lead broke and pin remained in the header.The event was resolved by explanting and replacing the lv lead and device due to normal eri.The patient was in stable condition.Related to manufacturer report number: (b)(4).

Manufacturer Narrative

The reported event was failure to remove lead from header.As received, a partial lead was returned in two pieces.Dimensional analysis found the diameters of the connector ring electrodes, and the connector seal zones found to be within specification.The is-4 connector pin could not be measured due connector pin not returned with the lead which is consistent with procedural damage.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found during visual inspection of the lead an external insulation abrasion breaching the lead insulation and exposing the inner coil at the middle region of the lead.The cause of the external insulation abrasion is consistent with friction to another device or feature of the heart.

Manufacturer Narrative

The reported event of failure to remove lead from header was not confirmed.As received, a partial lead was returned in three pieces.Dimensional analysis found the diameters of the is-4 connector pin, connector ring electrodes, and the connector seal zones found to be within specification.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found during visual inspection of the lead found an external insulation abrasion breaching the lead insulation and exposing the inner coil at the middle region of the lead.The cause of the external insulation abrasion is consistent with friction to another device or feature of the heart.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11037167
• MDR Text Key: 222364844
• Report Number: 2017865-2020-23111
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: 4087909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/03/2021; 02/23/2021
• Supplement Dates FDA Received: 02/04/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUADRA ASSURA MP ICD; QUADRA ASSURA MP ICD