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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97713
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580)
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 an implantable neurostimulator (ins). It was reported that the ins never worked. The patient's healthcare provider (hcp) said it was fine and that they can just live with it. The patient had been having a lot of health issues due to it. Some issues such as sciatica pain (>&<) a lot of leg pain, back, neck pain. The patient was just in the hospital and the doctors all believe its due to this ins. My health keeps getting worse.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key12138223
MDR Text Key264761064
Report Number3004209178-2021-10556
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 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2014
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/08/2013
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: 07/08/2021 Patient Sequence Number: 1
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