MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3242

Device Problems Failure to Disconnect (2541); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2021-24271.Related manufacturer reference number: 2017865-2021-24272.It was reported that the patient presented in clinic for a generator change procedure.During the procedure, the right atrial (ra) and right ventricular (rv) leads could not be removed due to tissue in the header of the pacemaker.Additionally, the ra and rv leads insulation was damaged during the procedure.The pacemaker was removed and replaced.Both leads were capped and the rv lead was replaced on (b)(6) 2021.The patient had no adverse consequences.

Manufacturer Narrative

H6 should include 2541 - failure to disconnect.

Manufacturer Narrative

The reported inability to remove the leads from the header was not confirmed in the laboratory.The device was found to have the original sbp (scalable brady platform) header design which is not compatible with lead connectors.The root cause is associated with the is-1 bore in sbp models having dimensions that are smaller in certain areas.The cause of the inability to remove leads was the header design.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12080664
• MDR Text Key: 258913382
• Report Number: 2017865-2021-24270
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

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: 03/31/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4787469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/29/2021; 09/07/2021
• Supplement Dates FDA Received: 06/30/2021; 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS; TENDRIL STS; TENDRIL STS
• Patient Age: 90 YR