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

Model Number	3107-36
Medical Device Problem Codes	Premature Discharge of Battery (1057); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for follow-up.Upon interrogation, it was noted that the battery of the implantable cardioverter defibrillator was depleted and garbled code was displayed on the programmer.The premature battery depletion was suspected to have been caused by high output settings due to patient's health condition.The device was explanted and replaced.The patient was stable post-procedure.
Additional Manufacturer Narrative
The reported field event of a text anomaly on the programmer screen was confirmed in the laboratory via review of the screenshots from the field which showed invalid characters.The text corruption was not present on printouts collected by the laboratory during analysis.The cause of the invalid characters could not be determined.The reported field event of premature battery depletion was not confirmed in the laboratory.The device was testing on the bench and no anomalies were found.Longevity calculations were performed, and the battery depletion was found to be normal.

• Brand Name: PROMOTE CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7803176
• Report Number: 2017865-2018-12188
• Device Sequence Number: 16621486
• 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
• Report Date (Section B): 08/27/2019

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: 02/29/2016
• Device Model Number: 3107-36
• Device Catalogue Number: 3107-36
• Device Lot Number: 4784837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 08/27/2019
• 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: Required Intervention
• Patient Age: 59 YR