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	08/26/2018
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
During follow-up, a diagnostic issue was noted on the device due to a false alert of eri.However, no actual eri alert was recorded on merlin.Net.No intervention was performed to resolve the event and the patient was in stable condition.
Event or Problem Description
The device was explanted to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
Additional information: the field event of an elective replacemet indicator (eri) alert could not be confirmed in the lab.Programmer printouts, device image and the session records from the field were reviewed and no eri alert was observed.A longevity calculation was performed based on the programmed settings and usage data.The calculation showed the battery depletion was normal.A bench test was performed on the icd and the device was found to be normal; telemetry, pacing, sensing, impedance, and patient notifier were tested on the bench; no anomaly was detected.No sources of high current were noted.

• 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: 7927532
• Report Number: 2938836-2018-11060
• Device Sequence Number: 1797395
• Product Code: NVZ
• UDI-Device Identifier: 05414734502634
• UDI-Public: 05414734502634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2019

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: 08/31/2011
• Device Model Number: CD1215-36
• Device Lot Number: 3088722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 11/11/2019
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/05/2018; 11/12/2019
• 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: 53 YR