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

Model Number	CD1215-36Q
Medical Device Problem Codes	Failure to Charge (1085); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
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 patient received multiple inappropriate shocks due to atrial fibrillation.On (b)(6) 2019 the patient's implantable cardioverter defibrillator was interrogated.Upon review, the patient's device exhibited a charge time-out alert.The patient was stable.No further information was available.
Event or Problem Description
New information received on (b)(4) 2019 indicates that the charge time-out alert was the result of normal behavior following multiple high voltage shocks in a short duration.No interventions were performed.

• Brand Name: CURRENT ACCEL VR 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: 8305197
• Report Number: 2017865-2019-01687
• Device Sequence Number: 16181698
• Product Code: NVZ
• UDI-Device Identifier: 05414734503044
• UDI-Public: 05414734503044
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 06/30/2013
• Device Model Number: CD1215-36Q
• Device Lot Number: 3567630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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