MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT+ DR DUAL-CHAMBER ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Discomfort (2330)
Date of Event	08/20/2020
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 an asymptomatic patient presented in clinic during follow-up, and backup vvi was observed.A download was not performed due to a low battery status.The patient also received an inappropriate shock prior to the backup operation.Device replacement will be scheduled at normal eri.The patient condition is stable.
Event or Problem Description
New information notes that the device was explanted due to an upgrade.No patient symptoms were reported.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed in the lab.The device entered bvvi after two consecutive resets within 32 seconds of each other.The cause of the bvvi operation is consistent with an integrated circuit anomaly.The device was taken out of bvvi and functionally tested; no anomaly was detected.The device functionality was bench tested and no anomaly was detected.

• Brand Name: CURRENT+ DR DUAL-CHAMBER ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10608170
• Report Number: 2938836-2020-08497
• Device Sequence Number: 16432025
• Product Code: NVZ
• UDI-Device Identifier: 05414734503723
• UDI-Public: 05414734503723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2021

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: 01/31/2011
• Device Model Number: CD2211-36
• Device Catalogue Number: CD2211-36
• Device Lot Number: 2831083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 08/13/2021; 11/12/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 08/26/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male