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

Model Number	1207-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter defibrillator exhibited premature battery depletion.The device was explanted.The patient was stable.
Additional Manufacturer Narrative
The reported event of longevity anomaly was confirmed.In-lab assessment and testing showed normal device function and a longevity estimate showed normal battery depletion.The cause of the incorrect longevity estimation observed in the field was undetermined.

• Brand Name: CURRENT VR RF
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8422457
• Report Number: 2938836-2019-01830
• Device Sequence Number: 2227475
• 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: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 02/28/2011
• Device Model Number: 1207-36
• Device Catalogue Number: 1207-36
• Device Lot Number: 3096460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); 3650, (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention