MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2211-36Q
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Reset Problem (3019)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	09/16/2019
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
It was reported that the patient presented in the emergency room after receiving several shocks from their device.The device was noted to be in back up mode because of low battery power.Voltage and error codes showed that the device's battery level was significantly lower than the elective replacement indicator levels.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
Additional information: the reported field event of backup vvi (bvvi) was confirmed in the laboratory.Upon received, the device was detected in backup defibrillation only (dfo).The device was tested on the bench and functioned normally.A longevity calculation was performed based on the parameter settings, and it was normal.Inappropriate shock was not confirmed, and the cause was undetermined.

• Brand Name: CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9141237
• Report Number: 2938836-2019-14230
• Device Sequence Number: 3007809
• Product Code: NVZ
• UDI-Device Identifier: 05414734503709
• UDI-Public: 05414734503709
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 05/31/2011
• Device Model Number: CD2211-36Q
• Device Catalogue Number: CD2211-36Q
• Device Lot Number: 2882878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 03/10/2020
• 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