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

Model Number	1207-30
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net transmission.Premature battery depletion was noted on the patient's implantable cardioverter defibrillator (icd).The device was explanted and replaced on 9/10/2018.Patient was stable post procedure.
Additional Manufacturer Narrative
The reported event of premature depletion could not be confirmed in the lab.Interrogation of the device revealed the device was above the elective replacement indicator when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Pacing, sensing, impedance, hv output, patient notifier was tested and no anomaly was detected.The cause of the field event remains undetermined.

• 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: 7904163
• Report Number: 2017865-2018-14353
• Device Sequence Number: 169386
• Product Code: LWS
• UDI-Device Identifier: 05414734501934
• UDI-Public: 05414734501934
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 11/30/2010
• Device Model Number: 1207-30
• Device Lot Number: 2801413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 06/07/2019
• 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