MAUDE Adverse Event Report: ABBOTT CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36Q
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.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 a clinic follow-up, a vibratory alert was unable to be delivered by the device during testing.Technical support was contacted, but no intervention has been performed at this time.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
Additional information: h3 and h6.The reported field event of patient notifier anomaly was confirmed in the lab.Interrogation of the device revealed that the device was above the elective replacement indicator (eri) when received for analysis.A longevity calculation was performed based upon programmed settings and usage data in the device image.The calculations revealed that the battery depletion was normal up to the event date.The device's functionality was bench tested regarding telemetry, pacing, sensing, impedance, high voltage (hv) output, and hv shock.The patient notifier failed to vibrate during the bench test.The cause of the anomaly was due to a patient notifier component failure, however, the cause of the failed patient notifier component could not be conclusively undetermined.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
Additional information received that the device was explanted to resolve the event.The patient was stable and will continue to be monitored.

• Brand Name: CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10146028
• Report Number: 2938836-2020-06778
• Device Sequence Number: 16914446
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020

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: 02/28/2014
• Device Model Number: CD2211-36Q
• Device Catalogue Number: CD2211-36Q
• Device Lot Number: 3795932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 11/13/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 10/12/2020; 11/16/2020
• 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