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

Model Number	2207-36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure event observed during analysis.Final analysis found premature battery depletion.Bench testing on the device was performed, and no sources of high current were noted.In further analysis of the battery, lithium clusters were observed, but at the time of analysis the clusters did not appear to be in a location or size that would be sufficient to cause an internal short of the battery.As a result, the cause of the premature battery depletion could not be conclusively determined.However, from these analyses, in the absence of other root causes, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: CURRENT DR 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: 8462226
• Report Number: 2938836-2019-02245
• Device Sequence Number: 2746349
• Product Code: LWS
• UDI-Device Identifier: 05414734501927
• UDI-Public: 05414734501927
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2010
• Device Model Number: 2207-36
• Device Lot Number: 3099279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1