MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, premature battery depletion was reported on the device which was observed to have reached elective replacement indicator (eri).Abbott technical support reviewed the session records and reported the battery longevity appeared within normal limits and could not rule out overestimated at a previous follow up visit.The device was explanted and replaced as it was at eri and will be returned for analysis to determine if the battery premature depleted.The patient was stable.
Additional Manufacturer Narrative
The device was returned for a diagnostic anomaly.The field reported a discrepancy in the longevity projections.The device was tested on the bench and was revealed to be normal.Additionally, the device was revealed to be within estimated longevity.The device¿s battery voltage adc (analog to digital converter) function was tested and was revealed to be normal.The cause of the discrepancy in the programmer¿s estimation of remaining longevity, near elective replacement indicator (eri), was not determined.

• Brand Name: CURRENT+ DR DUAL-CHAMBER ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11349948
• Report Number: 2017865-2021-09042
• Device Sequence Number: 16980222
• Product Code: NVZ
• UDI-Device Identifier: 05414734503723
• UDI-Public: 05414734503723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/25/2021

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: CD2211-36
• Device Catalogue Number: CD2211-36
• Device Lot Number: 3919597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 05/16/2021; 05/25/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/20/2021; 05/25/2021
• 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