MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D314VRG
Medical Device Problem Code	Battery Problem: High Impedance (2947)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis revealed that the device analysis confirmed that the device did not charge efficiently with the original device battery.The device charged nominally when the battery was replaced with an external supply.No hybrid anomalies were found.The results were consistent with the device battery causing the excessive charge time.Battery analysis revealed that there was no lithium plating near the cathode tab.Lithium severing observed in anode segments 3, 7 (partial), and 8 (partial).Lithium severing in anode segment 3 appeared to be severe enough to cause a high battery resistance and reduced capacity.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The device was replaced due to reaching elective replacement indicator.The device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA XT VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• MDR Report Key: 12599485
• Report Number: 9614453-2021-03930
• Device Sequence Number: 3473017
• Product Code: LWS
• UDI-Device Identifier: 00613994678164
• UDI-Public: 00613994678164
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: Lay User/Patient
• Device Expiration Date: 03/14/2012
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: 694765 LEAD
• Patient Age: 65 YR