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

Model Number CD2211-36Q

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  Injury  

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 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.

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.

Manufacturer Narrative

Further information was requested but not received.

Event 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
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10146028
• MDR Text Key: 194933194
• Report Number: 2938836-2020-06778
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 09/29/2020; 11/13/2020
• Supplement Dates FDA Received: 10/12/2020; 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention