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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 Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994); Seizures (2063); Complaint, Ill-Defined (2331); Electric Shock (2554)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The patient reported that she was experiencing ¿shocking sensations¿ down her legs and it felt like a ¿seizure. ¿ the patient reported that she was getting black and blue marks on her body from the shocking sensations. The patient noted that her ins was charged but her stimulation was turned off. The patient reported that she fell ¿against a tree¿ about 2 weeks ago and it could be related. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that she went back on her medicine around (b)(6) of 2019 and it's not controller her seizures anymore and she has another seizure last night and she is scared of the ins. The patient stated she used the ins last night because the seizures caused excruciating pain, and they are still experiencing shocking in their left leg. The patient stated she removed the battery from her patient programmer (pp), but was still getting shocked. Additional information was reported that the patient called the rep on (b)(6) 2020, but described sensations that sounded like typical stimulation. The patient stated she took the batteries out of her remote controller, but the sensation was still present. The rep explained to the patient that taking the batteries out of the remote did not turn the stimulation off, but that she had to turn the stimulation off using the grey button. The patient has an upcoming appointment on (b)(6), and patient's issues will be assessed then. No further complications were reported. No additional patient symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient on (b)(6) 2020. They reported the same information they reported previously (ins not working properly / shocking whole body when ins is off). They have tried reprogramming but that has not resolved the issue. The patient noted they fell twice since (b)(6) 2019, and they think that has something to do with it. The patient wants the ins removed, but their physician redirected them to talk to the rep. The patient also provided their new name and address information. It was noted the patient spoke with the rep the morning of (b)(6) 2020. No further complications were reported or anticipated.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9403242
MDR Text Key177415067
Report Number3004209178-2019-22966
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/28/2018
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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