MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA MRI XT DR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDMB1D1

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Protective Measures Problem (3015)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that the implantable cardioverter defibrillator (icd) delivered a shock during sexual intercourse.The patient alleged that the icd was defective and that a different time the icd didn't make an alert.The icd remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI XT DR SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 10495037
• MDR Text Key: 206104265
• Report Number: 3004209178-2020-15417
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169837713
• UDI-Public: 00643169837713
• 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: 09/04/2020

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: 09/28/2020
• Device Model Number: DDMB1D1
• Device Catalogue Number: DDMB1D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/04/2020
• Date Device Manufactured: 04/10/2019
• 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): Life Threatening
• Patient Age: 47 YR