MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2215-36Q
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	07/08/2018
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
It was reported that the asymptomatic patient presented in clinic after receiving high voltage therapy.Upon review, the implantable cardioverter defibrillator exhibited backup vvi operation.It is unknown if the therapy was appropriate.No sources of electromagnetic interference were noted.A device download was unable to be performed due to an unexplained power on reset.On (b)(6) 2018 the device was explanted and replaced.The patient was stable throughout.
Additional Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a power-on reset (por) that occurred which the device was in the process of delivering high voltage therapy.The device was tested on the bench.The cause of the por could not be determined.

• Brand Name: CD2215-36Q CURRENT ACCEL DR ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7726778
• Report Number: 2017865-2018-11023
• Device Sequence Number: 11012003
• Product Code: NVZ
• UDI-Device Identifier: 05414734503075
• UDI-Public: 05414734503075
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 10/31/2011
• Device Model Number: CD2215-36Q
• Device Lot Number: 3253266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 07/22/2019
• 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
• Patient Age: 56 YR