MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D314DRM
Medical Device Problem Codes	Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2022
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) reached end of service (eos) and charge circuit inactive occurred.In addition, alerts were triggered for charge circuit timeout and for charge time greater than 30 seconds.The icd was explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA XT DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14565516
• Report Number: 3004209178-2022-07006
• Device Sequence Number: 5082423
• Product Code: LWS
• UDI-Device Identifier: 00613994714572
• UDI-Public: 00613994714572
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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: 07/14/2013
• Device Model Number: D314DRM
• Device Catalogue Number: D314DRM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2022
• Initial Report FDA Received Date: 06/01/2022
• Date Device Manufactured: 01/17/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M55 LEAD, 5076-45 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 89 KG