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

Model Number	CD1215-36
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a follow-up, the device was interrogated and revealed two alerts for elective replacement indicator (eri).One of the eri alerts was incorrectly delivered.The device was explanted and replaced due to normal eri and the patient was stable.
Additional Manufacturer Narrative
The device was returned due to a diagnostic anomaly.The device was at eri when received.A longevity calculation was performed based on the programmed settings and usage data.The calculation showed the battery depletion was normal.However, it was revealed that the longevity estimate given to the field by the programmer was incorrect.Testing was performed on the icd and the icd was found to be normal; telemetry, pacing, sensing, impedance, hv output, hv shock, and patient notifier were tested on the bench; no anomaly was detected.The root cause for the inconsistent remaining longevity estimate near eri could not be conclusively determined.

• 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: 7681325
• Report Number: 2938836-2018-08604
• Device Sequence Number: 1409945
• Product Code: NVZ
• UDI-Device Identifier: 05414734502634
• UDI-Public: 05414734502634
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2010
• Device Model Number: CD1215-36
• Device Lot Number: 2921010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1