MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	3107-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2018
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
It was reported that during routine follow-up in clinic, device was found to reach eri and premature battery depletion was noted.Device was explanted and replaced.Patient¿s condition was stable.
Event or Problem Description
New information received notes that the physician believes that the high lv threshold caused faster battery depletion and battery was normal otherwise.
Additional Manufacturer Narrative
Model number should have been 1065t/86 rather than 1056k/86.
Additional Manufacturer Narrative
The reported field event of premature battery depletion was not confirmed in the lab.Interrogation of the device revealed the device was above eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage and programmed settings.Device was tested on the bench and no anomaly was detected.

• Brand Name: PROMOTE CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7608341
• Report Number: 2938836-2018-07957
• Device Sequence Number: 1623580
• Product Code: NIK
• UDI-Device Identifier: 05414734502221
• UDI-Public: 05414734502221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2018

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: 05/31/2015
• Device Model Number: 3107-36
• Device Catalogue Number: 3107-36
• Device Lot Number: 4364120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 08/01/2018; 10/11/2018
• Initial Report FDA Received Date: 06/16/2018
• Supplement Report FDA Received Date: 07/02/2018; 08/16/2018; 10/18/2018
• 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
• Patient Age: 83 YR
• Patient Weight: 45