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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, 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 Key6260907
MDR Text Key102628419
Report Number3004209178-2017-01145
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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