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

Model Number	1207-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	09/23/2019
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 presented in clinic for follow up.Upon review, the implantable cardioverter defibrillator exhibited premature battery depletion and the patient experienced increased fatigue.Patient was scheduled for replacement procedure.The patient was stable before, during, and after the follow up visit.
Event or Problem Description
New information received indicated that the patient was seen in clinic on (b)(6) 2019.The patient was stable prior to, during, and after the clinic visit.Battery longevity measurement estimated less than three months of battery left on the implantable cardioverter defibrillator.The patient was set up for a non-urgent out-patient replacement.
Event or Problem Description
New information received noted that the implantable cardioverter defibrillator has not yet reached elective replacement indicator (eri).
Additional Manufacturer Narrative
The results /method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information received noted that the implantable cardioverter defibrillator reached elective replacement indicator (eri) in early (b)(6) 2020 and the patient received a vibratory alert.The patient presented for explant procedure on (b)(6) 2020.The implantable cardioverter defibrillator was explanted and replaced.The patient was stable post procedure.
Additional Manufacturer Narrative
The device was returned due to a diagnostic anomaly.The cause of the diagnostic anomaly was undetermined.A longevity estimation was performed, and the battery voltage was found to be within expected longevity performance.

• Brand Name: CURRENT VR RF
• 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: 9154094
• Report Number: 2017865-2019-14613
• Device Sequence Number: 11399722
• Product Code: LWS
• UDI-Device Identifier: 05414734501941
• UDI-Public: 05414734501941
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 11/30/2011
• Device Model Number: 1207-36
• Device Catalogue Number: 1207-36
• Device Lot Number: 3308565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 01/06/2020; 02/26/2020; 12/08/2020; 12/08/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/21/2019; 01/15/2020; 03/17/2020; 12/15/2020; 12/15/2020
• 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
• Patient Age: 66 YR