MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a previous follow-up in june, the device longevity was estimated to be at 2-4 years.In july, the elective replacement indicator (eri) was observed on the device.At an in-clinic follow up, the device was not able to be interrogated with a programmer.Technical support was contacted and noted a drop in battery voltage.The device was explanted and replaced to resolve the event.The patient was stable with no consequences.
Additional Manufacturer Narrative
The field event of premature battery depletion was confirmed.Telemetry, sensing, pacing, lead impedance, high voltage charging, high voltage delivery and high voltage shock impedance were tested, and the device¿s function was normal.No high current drain sources were found throughout testing.The battery was analyzed by its manufacturer and no anomalies were found.The cause of the premature depletion is undetermined.

• Brand Name: CURRENT PLUS VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10407006
• Report Number: 2938836-2020-07889
• Device Sequence Number: 2552830
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• 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: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 03/31/2013
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 3503893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 03/26/2021
• 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