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

Model Number	PM3542
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented to clinic for follow up.Device interrogation revealed premature battery depletion on the pacemaker (pm).The physician elected to explant and replace the pm.The patient condition was stable.
Additional Manufacturer Narrative
Further information was requested but not yet received.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.The device was received with normal telemetry and output.Analysis performed did not identify any functional issues.Longevity assessment found the device was at elective replacement indicator (eri) voltage, consistent with high output mode found in the field settings.Visual inspection of the header attachment area detected an anomaly between the pre-cast header and titanium case.Feedthrough leak test was performed, indicating no sign of hermeticity breach.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16726464
• Report Number: 2017865-2023-17378
• Device Sequence Number: 7387576
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000081517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/28/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown