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

Model Number	1207-36
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
During remote monitoring, the device was at elective replacement indicator (eri).Technical support was contacted and suspected the battery voltage dropped more than expected.The device was explanted and replaced due to eri and suspected overestimation of battery longevity by the programmer at the previous follow-up.The patient was in stable condition.
Additional Manufacturer Narrative
Premature depletion was confirmed.Bench and ate testing showed normal device function.The battery was analyzed by its manufacturer and no anomalies were found.The cause of the premature depletion was undetermined.

• Brand Name: CURRENT VR RF
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10214567
• Report Number: 2938836-2020-07140
• Device Sequence Number: 11296130
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 01/31/2011
• Device Model Number: 1207-36
• Device Catalogue Number: 1207-36
• Device Lot Number: 2922533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 04/30/2021
• 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