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

Model Number	CD2211-36Q
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
The patient presented to the hospital after receiving a shock.Upon interrogation, the device was found in backup mode due to a power on reset (por).The device was explanted and replaced.The patient was stable with no adverse consequences.Related manufacturer report number: 2938836-2019-06279.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.The device was in backup mode upon receipt in the lab.The cause of the backup operation was due to a power-on reset (por) during high voltage therapy delivery.An arc was observed on the can, which indicated that the lead arced to the can during high voltage therapy, which caused the por.Further analysis was performed.An arc mark was present on the can of the device.Energy dispersive x-ray (edx) analysis confirmed lead material was present in the arc mark, which shows the root cause of the por and resulting backup operation was due to a lead anomaly.

• 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: 8816514
• Report Number: 2938836-2019-06277
• Device Sequence Number: 342855
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 04/30/2016
• Device Model Number: CD2211-36Q
• Device Lot Number: 4860984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7122Q/65, BPA044892
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention