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

Model Number PM3562

Device Problem Difficult to Insert (1316)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that during a device exchange procedure, the left ventricular lead was unable to be fully inserted into the header of the pacemaker.The physician elected to use another pacemaker which was able to be successfully implanted.Their were no patient consequences throughout.

Manufacturer Narrative

Additional information: d10.The reported complaint of unable insert the lv lead into the lv-connector was confirmed.Analysis testing found the lv-setscrew was blocking lead insertion into the lv-connector.The user¿s manual states it is the user¿s responsibility to retract the setscrews in the device connectors so that the pacing lead terminal pins can be fully inserted.No device anomalies were found.

• Brand Name: QUADRA ALLURE MP 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: 10245961
• MDR Text Key: 197972462
• Report Number: 2017865-2020-08842
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• 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: 09/15/2020

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: 06/30/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000096070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR