MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow up, in was noted that it was not possible to interrogate the device.The device was explanted to resolve the event and the patient was stable with no adverse consequences reported.Additional information was requested but not available.
Additional Manufacturer Narrative
The device was received in backup operation.Backup occurred due to low battery voltage trigger consistent with exposure to cold temperatures.After cutting open the device, battery was revealed to have reached end of life.The manufacturing to receive date exceeds the total projected longevity based on field settings and is considered normal battery depletion.Telemetry testing after replacing the device battery revealed no anomalies.The device exhibited normal characteristics after furthering testing with a new battery.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8122277
• Report Number: 2017865-2018-18086
• Device Sequence Number: 1203993
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2006
• Device Model Number: 5366
• Device Lot Number: 3023053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention