MAUDE Adverse Event Report: MEDTRONIC, INC. WIREX; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number WIREX

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Electric Shock (2554)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 2490h9, serial# (b)(4).

Event Description

It was reported that the patient called for assistance trying to send a transmission with the remote monitor and the e-cellular accessory.During troubleshooting the patient reported getting a shock from the accessory when plugging it in for a power cycle.A new accessory was sent to the patient.The monitor remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: WIREX
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6162467
• MDR Text Key: 62088011
• Report Number: 2182208-2016-02764
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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 Model Number: WIREX
• Device Catalogue Number: WIREX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: 10/14/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 2490H, MONITOR, SESR01, IPG, 4076, LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR