MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT VR MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DVPB3D1

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 11/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported receiving shocks shortly after the device was implanted.Additional information indicated that the shocks were for atrial fibrillation with rapid ventricular response.Reprogramming was performed and the implantable cardioverter defibrillator(icd) remains in use.The patient also indicated that they thought they heard "3 beeps".No alerts were noted to have occurred.No further patient complications have been reported as a result of this event.

• Brand Name: COBALT VR MRI SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10970179
• MDR Text Key: 220279204
• Report Number: 9614453-2020-04051
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000178499
• UDI-Public: 00763000178499
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2020

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: 11/28/2021
• Device Model Number: DVPB3D1
• Device Catalogue Number: DVPB3D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/08/2020
• Date Device Manufactured: 06/04/2020
• 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
• Treatment: 693565 LEAD.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR