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)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During a follow-up, the device was unable to be interrogated.No intervention was performed to resolve the event and the patient was stable.
Event or Problem Description
During a follow-up, the device was unable to be interrogated.The device was explanted and replaced to resolve the event and the patient was stable.
Additional Manufacturer Narrative
The reported event of loss of telemetry was confirmed.The device could not be interrogated due to code corruption which also resulted in backup operation.No information was received regarding possible electromagnetic interference.The cause of the code corruption could not be determined.After correcting the code corruption and reloading product code, the device could be interrogated, and further telemetry tests revealed no anomalies.Further analysis found the device battery is still above elective replacement battery levels.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• 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: 7689646
• Report Number: 2017865-2018-10304
• Device Sequence Number: 19477940
• Product Code: LWP
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/19/2018

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: 12/31/2008
• Device Model Number: 5366
• Device Lot Number: 2979580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 10/15/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/14/2018; 10/19/2018
• 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