MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT PLUS VR, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1211-36Q
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic.Upon interrogation, it was observed that the implantable cardioverter-defibrillator (icd) exhibited premature battery depletion.The icd was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
Correction: previously reported d6a should have been 'aug 6, 2019', and previously reported d6b should have been 'nov 16, 2021'.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.Interrogation of the device revealed the had reached end of service (eos) upon receipt.A longevity calculation based upon device settings and usage data showed battery depletion was normal.Telemetry, pacing, sensing, impedance, hv output, hv shock, and patient notifier were tested on the bench and found to be normal.No anomalies were detected.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13006740
• Report Number: 2017865-2021-39090
• Device Sequence Number: 13926699
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: 05414734503716
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

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: 11/30/2019
• Device Model Number: CD1211-36Q
• Device Catalogue Number: CD1211-36Q
• Device Lot Number: S000060830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 01/28/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 12/29/2021; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• 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: Unknown