MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL DR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2215-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
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 the implantable cardioverter defibrillator exhibited premature depletion.The device was removed and replaced with a competitor device while the patient, who lived in (b)(6), was abroad in (b)(6).The patient was reported to be stable post-procedure.
Additional Manufacturer Narrative
The reported field event of premature battery depletion was not confirmed in the laboratory.Longevity calculation was performed and found the battery depletion was normal based on the device usage.The longevity estimate reported by the field appeared anomalous and was a diagnostic anomaly.A root cause for the inconsistent remaining longevity estimate near eri indicated by the programmer was not identified.

• Brand Name: CURRENT ACCEL DR, 36J
• 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: 8102357
• Report Number: 2017865-2018-17674
• Device Sequence Number: 1599368
• Product Code: NVZ
• UDI-Device Identifier: 05414734502641
• UDI-Public: 05414734502641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 04/30/2011
• Device Model Number: CD2215-36
• Device Lot Number: 3096094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 09/23/2019
• 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