MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CURRENT ACCEL VR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1215-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow-up in clinic, the device was interrogated and the remaining longevity was much lower than expected.It was speculated that the remaining longevity may have been overestimated at the previous follow-up appointment.The device was explanted and replaced and the patient was stable with no consequences.
Additional Manufacturer Narrative
The device was returned for a diagnostic anomaly.The field reported that the device reached eri earlier than previous projections.The device was tested on the bench and found to be normal.The device was found to be within estimated longevity.The device¿s battery voltage adc function was tested and found to be normal.The cause of the discrepancy in the programmer¿s estimation of remaining longevity, near eri, was not determined.
Event or Problem Description
Related manufacturer reference number: 2017865-2019-05310.

• Brand Name: CURRENT ACCEL VR, 36J
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8073759
• Report Number: 2938836-2018-12165
• Device Sequence Number: 19262583
• Product Code: NVZ
• UDI-Device Identifier: 05414734502634
• UDI-Public: 05414734502634
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 05/31/2011
• Device Model Number: CD1215-36
• Device Lot Number: 3082125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 04/12/2019
• 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
• Patient Age: 71 YR