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

Model Number	CD2215-36
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation is being submitted related to manufacturing report number 2938836-2014-14696.No conclusion code available.The device was tested on the bench and the reported field event of capacitor maintenance timeout was confirmed in the laboratory.The high voltage capacitors were sent to the manufacturing site for further evaluation and an internal high voltage capacitor anomaly was found.The root cause of the extended charge time was an internal high voltage capacitor anomaly.Abbott conducted a review of complaint files under a non-product capa and identified that a report was required to be filed as a result of the subject event.Distributed devices are not affected by the capa.Additionally, no new risks were identified, and no product-related actions are required as a result of this report submission.Furthermore, product performance trending is not impacted by this report, and no new mitigation actions are required as a result of this report.
Event or Problem Description
Device evaluation is being submitted related to manufacturing report number 2938836-2014-14696.

• Brand Name: CURRENT ACCEL DR, 36J
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8104461
• Report Number: 2938836-2018-12463
• Device Sequence Number: 11280249
• Product Code: NVZ
• UDI-Device Identifier: 05414734502641
• UDI-Public: 05414734502641
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2010
• Device Model Number: CD2215-36
• Device Lot Number: 5192028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2015
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1