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); Device Sensing Problem (2917); Protective Measures Problem (3015)

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

Event Date 06/27/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 2088tc, product type: lead, implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) delivered shocks for what was possible supra ventricular tachy cardia (svt) with rapid ventricular response (rvr).In addition, the icd was toning continuously.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: 10309732
• MDR Text Key: 199987408
• Report Number: 3004209178-2020-12640
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

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: 10/28/2019
• Device Model Number: DDMB1D1
• Device Catalogue Number: DDMB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/22/2020
• Date Device Manufactured: 05/04/2018
• 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: 67 YR