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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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 who was implanted with an implantable neurostimulator (ins) for complex reg pain syndrome type i and spinal pain. It was reported that the patient noticed years ago that when they lie down, their whole body feels like it is being mildly electrocuted. Pt said this during call when reporting a damaged programmer antenna and couldn't turn off their stimulation. Pt mentioned they had to sit up all night and only got 30 minutes of sleep.   [please refer to (b)(4) for damaged antenna].
 
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Brand NamePRIMEADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11628264
MDR Text Key245193493
Report Number3004209178-2021-05619
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 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2015
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/23/2013
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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