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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 Intermittent Continuity (1121); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515); Electric Shock (2554)
Event Date 11/01/2019
Event Type  Injury  
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 a neurostimulator for non-malignant pain. It was reported that the stimulation was cutting in and out and it was zapping the patient mainly from under the ribs then down to her leg. The patient stated that she has had to turn the stimulation down by over 1. 0 ma. When the stim was too strong, it caused the patient to shake a lot, causing a non-epileptic seizure. It was further indicated that the stim seemed to have shifted and it was like ¿a manual shift car that stalled and kick back up¿. There were no reports of trauma, falls, emi, or activity. In the end, the patient was redirected to follow-up with their healthcare professional (hcp) to check the system. There were no further complications reported or anticipated.
 
Manufacturer Narrative
Product id: 37761, product type: recharger. Information pertaining to this event was previously reported in regulatory report # 3004209178-2020-04160.   any additional information pertaining to the event will be submitted as a supplemental to this report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient. It was reported that their recharger wouldn't last very long due to having to charge frequently because they were on hd programming. The patient mentioned that they were meeting with their healthcare provider (hcp) and a manufacturer representative on (b)(6) 2020 to schedule the replacement of their implantable neurostimulator (ins). It was confirmed that this was due to normal battery depletion. The patient mentioned that they were switched to hd mode, which had a higher frequency than their battery was supposed to use. The patient stated that they've had their ins for five years, which was a normal time frame for the type of programming that they had, and they were okay with it and everything was fine. It was reported that the patient was trying to find something better suited for their pain that had increased. It was noted that the patient¿s pain had been increasing over the last year or so, and they were not getting good enough coverage. It was not confirmed if the increase in pain started happening around the same time that the patient¿s ins started to ¿go bad¿ and not work well. No further complications were reported or anticipated. Indication for use is non-malignant pain. Additional information was received and it was reported that they started having surges of stimulation and it was erratic. The pain had changed over the last 5 years and they didn't get as good of coverage. It was reported there weren't circumstances that led to the device going bad and not working. The patient was changed to a higher frequency which led to them needing to charge twice a day for several hours each time. The stimulator had been changed and they were working to build programs to get better coverage. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9438330
MDR Text Key175072837
Report Number3004209178-2019-23379
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 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2015
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 Received04/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2019 Patient Sequence Number: 1
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