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

Model Number	CD1211-36
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2020
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
During an in-clinic follow up, an alert for charge time out was observed on the device.A manual capacitor maintenance was conducted but was unsuccessful.No intervention has been conducted at this time but device explant is expected at the next in-clinic follow up.The patient was stable with no consequences.
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.Additional information: b1, b2, b5, d7, h1, and h10.
Event or Problem Description
Additional information received indicating that the device was explanted and replaced to resolve the event.There were no known patient consequences.
Additional Manufacturer Narrative
The reported event of charging anomaly was confirmed in the lab.As received, interrogation of the device revealed the device was above the elective replacement indicator (eri).Pacing, sensing, impedance, high voltage output, and patient notifier were tested, and no anomaly was detected.The capacitors were sent to the manufacturer and the extended charge time was unable to be reproduced.The cause of the field event 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: 10652552
• Report Number: 2938836-2020-08496
• Device Sequence Number: 19713900
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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,Followup,Followup
• Report Date (Section B): 04/21/2021

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: 07/31/2014
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 3912430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 01/22/2021; 04/09/2021
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/05/2020; 01/22/2021; 04/21/2021
• 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