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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 Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892)
Patient Problems Sleep Dysfunction (2517); Electric Shock (2554)
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 regarding their implantable neurostimulator (ins). Information was reported that the patient stated for the last 3-4 years when he's trying to sleep he feels little shocks going down his leg, almost like restless leg syndrome. The patient stated this is also why he is looking into having the device removed. The patient mentioned he is unable to recharge his ins for the last 3-4 years, so no further troubleshooting was done. The patient stated their battery ran out and the patient wants to talk to someone about getting it removed. The patient stated his ins will no longer charge. The patient also first noticed this about 3-4 years ago, and he longer uses it since he is seeing a chiropractor and feels he doesn't need it. The patient inquired about who he speaks to regarding getting the ins removed. No further information was reported.
 
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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 Key10108819
MDR Text Key193420579
Report Number3004209178-2020-09530
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
Report Date 06/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2017
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 Received05/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/09/2016
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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