MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Date 06/01/2016

Event Type  malfunction  

Event Description

Information received from the consumer regarding a patient who was implanted with a neurostimulator for spinal pain reported that they got electrocuted.It was described that the patient went to a place where they hold bears and there was an electric fence there.They did not see the sign and ¿kept getting electrocuted.¿ the patient stated that it got worse and worse and ¿was really in a bad area and had to run away.¿ the patient was going to follow up with their healthcare professional (hcp).Additional information was received from the consumer.It was reported that when they were within 10-20 feet of the electrical fence their device began shocking them with erratic electrical pulses.It was reported that they felt ill, had to lay down and took about 24 hours to feel somewhat normal.It was also reported that the patient thought their device was broken as a result of the event but after about 24-28 hours they felt it return back to normal function.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6260907
• MDR Text Key: 65108485
• Report Number: 3004209178-2017-01145
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Date Device Manufactured: 05/11/2016
• 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 Age: 48 YR