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 Failure to Interrogate (1332); No Pacing (3268)

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

Event Type  Injury  

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

It was reported that a patient presented in clinic.Upon device evaluation, the patient's pacemaker was unable to be interrogated.The device would be explanted on a later date.Patient was in stable condition.

Event Description

New information noted that the pacemaker had no output.The device was explanted and replaced.Patient condition was not reported.

Manufacturer Narrative

Field complaints of no output and no telemetry were confirmed.Visual examination of the device found a hole in the can which is consistent with damage during manufacturing.Foreign material was found to have leaked into the can causing battery short and hybrid damage.Battery was found to have reached end of life due to shorting.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8502173
• MDR Text Key: 141573979
• Report Number: 2017865-2019-05164
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

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: 09/30/2018
• Device Model Number: PM3262
• Device Lot Number: A000037729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 03/29/2019; 05/15/2019
• Supplement Dates FDA Received: 04/16/2019; 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR