MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D314VRG
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited premature battery depletion and was unable to be interrogated.The device was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The returned device indicated shorting/low impedance in the battery.Hybrid analysis confirmed a severely depleted battery.When powered by an external supply, the system current drain was nominal, and the device was fully functional throughout the analysis.No battery depletion mechanism, such as high system current drain, was observed.No hybrid anomalies were found.Battery analysis revealed that lithium-plating breaches were found along the top edge of the anode separator in segment 2, adjacent to the exposed cathode tab.Plated-lithium extended from the breached opening and touched the cathode tab.Based on this analysis, the premature battery depletion resulted from an internal lithium-plating short.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA XT VR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 7416459
• Report Number: 9614453-2018-00996
• Device Sequence Number: 1482170
• Product Code: LWS
• UDI-Device Identifier: 00613994678164
• UDI-Public: 00613994678164
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: Lay User/Patient
• Device Expiration Date: 03/28/2012
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 08/08/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/10/2018; 10/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR