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

Model Number	D314VRG
Medical Device Problem Codes	Failure to Charge (1085); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
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 patient heard audible tones and went to the emergency room.It was found that the device had a charge circuit timeout occur and that the charge time was noted to be greater than thirty seconds.It was also noted that a warning that atp (an ti-tachycardia pacing) and shock therapies will not be delivered: charge circuit inactive and that the device was at end of service (eos) and to replace immediately.The device was explanted and replaced.No patient complications have been reported as a result ofthis event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis confirmed that the device did not charge efficiently by observing a charge time out (cto) as received.The device charged nominally when the battery was replaced with an external supply.No hybrid anomalies were identified.Battery analysis revealed that there was localized lithium (li) discharge along the edges and partial li-severing.The li-severing resulted in a reduced li anode surface are a.The device was returned due to excessive charge time (ect) and charge time out (cto) alerts prior to recommended replacement time and subsequent explant.These excessive charge times and charge timeouts resulted from increased battery resistance induced by observed li-severing.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: 7254503
• Report Number: 9614453-2018-00156
• Device Sequence Number: 19147681
• Product Code: LWS
• UDI-Device Identifier: 00613994678164
• UDI-Public: 00613994678164
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 03/14/2012
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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