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

Model Number D314VRG

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that they were hearing an alert tone.The patient was referred to their physician for a device check.The implantable cardioverter defibrillator (icd) remains in use.No patient complications have been reported as a result of this event.It was further reported that the alert was due to elective replacement indicator (eri).It was further reported that the icd tested out of specification (oos) upon returned product analysis.

• Brand Name: PROTECTA XT VR
• Type of Device: 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
• 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: 11112836
• MDR Text Key: 227977140
• Report Number: 3004209178-2021-00085
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00613994677877
• UDI-Public: 00613994677877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2021

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: 11/14/2012
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2011
• 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: 65 YR