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

Model Number	D334DRG
Medical Device Problem Codes	Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Reset Problem (3019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5076-52, lead; implanted: (b)(6) 2006.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the implantable cardioverter defibrillator (icd) had reached eri (elective replacement indicator) approximately two years ago and is now alarming.It is suspected that an electrical reset has occurred and/or a charge circuit timeout/charge circuitinactive has occurred.The icd remains implanted.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA DR
• 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: 10670225
• Report Number: 3004209178-2020-17799
• Device Sequence Number: 2881716
• Product Code: LWS
• UDI-Device Identifier: 00613994677860
• UDI-Public: 00613994677860
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 06/28/2014
• Device Model Number: D334DRG
• Device Catalogue Number: D334DRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR