MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO JUNCOS PROTECTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	D334TRM
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
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 there was increased and elevated thresholds on the left ventricular (lv) lead.The lead was capped and replaced.It was also reported that the device had reached battery depletion early.The device was explanted and replaced.The patient is enrolled in the post approval network (pan) cardiac and vascular group (cvg) clinical study.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PROTECTA CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 7454451
• Report Number: 3004209178-2018-08672
• Device Sequence Number: 11003530
• Product Code: NIK
• UDI-Device Identifier: 00613994714619
• UDI-Public: (01)00613994714619(17)130714
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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: D334TRM
• Device Catalogue Number: D334TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018; 12/01/2025
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/01/2018; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2012
• 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: 6947M62 LEAD, 407652 LEAD, 419688 LEAD; 6947M62 LEAD, 407652 LEAD, 419688 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White