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

Model Number D314TRG

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a patient family member that the patient was not feeling well and when they presented to the clinic, the device battery had "went down" - when they had previously been told by the physician that there were "months left on the battery" - and the device had not triggered an alert as they were told it would.The patient family member stated the device malfunctioned by not triggering an alert and consequently the patient's health suffered.The device was explanted and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7781164
• MDR Text Key: 117132579
• Report Number: 3004209178-2018-18159
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994677884
• UDI-Public: 00613994677884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/14/2018
• Date Device Manufactured: 08/08/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR