MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5356

Device Problems Battery Problem: High Impedance (2947); Missing Test Results (3267)

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

Event Date 09/26/2018

Event Type  Injury  

Event Description

During follow-up, a threshold and sensing test could not be performed despite the battery longevity estimation showing half the battery left.In addition, the battery impedance was elevated.The device was explanted and replaced with no adverse consequences to the patient.

Manufacturer Narrative

The device was returned for evaluation and the device battery was below the elective replacement indicator (eri) voltage level when it was received.Initial testing performed confirmed the reported telemetry anomaly.Analysis of device image indicated that a false eri was triggered during the explant procedure, consistent with low battery voltage fluctuations occurring beyond the devices intended longevity.Longevity assessment was performed, indicating that the device was implanted beyond its projected longevity period.Additional functional testing was performed and test results indicated loss of telemetry when the battery voltage dropped below 2.17v.This is consistent with the combo ic anomaly resulting in devices loss of telemetry at near end of life battery levels.Actions have been taken to prevent reoccurrence.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7957114
• MDR Text Key: 123418942
• Report Number: 2017865-2018-15194
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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: 04/30/2007
• Device Model Number: 5356
• Device Lot Number: 3007201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2005
• 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): Hospitalization; Required Intervention