MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3211-36Q
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
During a scheduled follow-up, the device could no longer be interrogated due to premature battery depletion.The patient received multiple alerts regarding eri, but neglected to inform the clinic.The device was explanted and the patient was in stable condition.
Additional Manufacturer Narrative
The reported field event premature depletion was confirmed.The cause of the premature depletion was found to be due to high current.The cause of the high current was found to be due to an integrated circuit anomaly.No other anomalies were found.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8807700
• Report Number: 2938836-2019-06158
• Device Sequence Number: 326670
• Product Code: NIK
• UDI-Device Identifier: 05414734503679
• UDI-Public: 05414734503679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 03/31/2016
• Device Model Number: CD3211-36Q
• Device Lot Number: 4813744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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