MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT PLUS VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2020
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
Related manufacturer reference number: 2017865-2020-16896.It was reported that an asymptomatic patient presented to the emergency room for a vibratory alert that they had received from their implantable cardioverter defibrillator (icd) for capacitor time limit reached and high out of range defibrillation impedance for the right ventricular (rv) lead.Icd was explanted and replaced on (b)(6)2020.The existing rv lead had normal measurements at first but then exhibited high defibrillation impedance again.Rv lead was instead capped and replaced.An x-ray revealed the lead had externalized conductors.Patient was stable after the procedure.

• Brand Name: CURRENT PLUS VR
• 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: 10766771
• Report Number: 2017865-2020-16908
• Device Sequence Number: 11044414
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 06/30/2011
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 2899033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2020
• Initial Report FDA Received Date: 10/30/2020
• 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