MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334VRM
Medical Device Problem Code	Battery Problem: High Impedance (2947)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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.Battery analysis revealed that no evidence of internal shorting was found during destructive analysis.Lithium severing was seen on anode segment 8.Anode segments 3, 6, and 7 were found to be nearly severed.The charge timeout could likely be due to increased battery resistance induced by the observed lithium-severing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the device was returned to the manufacturer after being removed, and replaced for normal depletion.The device subsequently tested out of specification during the manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA VR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10877262
• Report Number: 3004209178-2020-20403
• Device Sequence Number: 19556955
• Product Code: LWS
• UDI-Device Identifier: 00613994714626
• UDI-Public: 00613994714626
• 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: 2012
• Device Explanted Year: 2019
• 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): 11/20/2020

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: 07/28/2013
• Device Model Number: D334VRM
• Device Catalogue Number: D334VRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR