MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36Q
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 2017865-2022-03436.During an in clinic follow up, an ocd (over current detection) alert was received on the device indicating a possible high voltage lead issue on the right ventricular (rv) lead.Technical support was contacted and noted shocks had not been delivered due to high defibrillation impedance on the rv lead.A lead fracture was suspected.Technical support recommended lead and device replacement.The rv lead and the device were explanted and replaced to resolve the event.The patient was stable.
Additional Manufacturer Narrative
The reported field event of over current detection (ocd) could not be reproduced in the lab.Visual inspection did not reveal any anomaly.The device was above elective replacement indicator (eri) upon receipt.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13541201
• Report Number: 2017865-2022-03437
• Device Sequence Number: 14407589
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: 05414734503716
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 11/30/2015
• Device Model Number: CD1211-36Q
• Device Catalogue Number: CD1211-36Q
• Device Lot Number: 4604544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown