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

Model Number	D334VRM
Medical Device Problem Codes	Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2018
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 patients implantable cardioverter defibrillator (icd) had triggered alerts for charge circuit timeout, charge circuit inactive, and long charge time prior to battery depletion.The device was extracted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated charge circuit inactive.Analysis of the device memory indicated charge circuit timeout.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was returned and analyzed.Analysis of the device found high internal battery resistance.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.Battery analysis revealed that lithium-severing was seen in turn 7.The device was returned due to an end of service (eos), excessive charge time (ect) and charge time out (cto) alerts.This charge timeout resulted from increased battery resistance induced by observed lithium-severing.If information is provided in the future, a supplemental report will be issued.

• 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: 7478319
• Report Number: 3004209178-2018-09813
• Device Sequence Number: 2183031
• Product Code: LWS
• UDI-Device Identifier: 00613994714626
• UDI-Public: 00613994714626
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/28/2018

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: 11/28/2013
• Device Model Number: D334VRM
• Device Catalogue Number: D334VRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/08/2018; 08/27/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/09/2018; 08/28/2018
• 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: 76 YR
• Patient Weight: 70