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

Model Number PM3262

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2020

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow-up.Upon review, the patient's pulse generator exhibited no left ventricular capture and a rise in impedance.The device also exhibited increased atrial capture thresholds, increased impedance and lead noise.The patient was screened and the lead pins did not appear to be properly inserted in the header.On (b)(6) 2020 the patient's presented for a revision procedure.During the procedure, the physician noted that they were unable to insert the pins any further than they were originally.The patient's device was removed and replaced.Both the right atrial and left ventricular leads tested normally and were reused with the new device without issue.The patient is recovering.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ALLURE MP 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: 10687180
• MDR Text Key: 211624031
• Report Number: 2017865-2020-15578
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PM3262
• Device Catalogue Number: PM3262
• Device Lot Number: P000096546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention