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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37712
Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Battery Problem (2885); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)
Patient Problems Pain (1994); Neck Pain (2433)
Event Date 06/30/2021
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 chronic low back pain, and failed back surgery syndrome. The reason for call was patient (pt) stated that her ins kicked back on a couple of weeks ago and the stimulation sensation has been getting stronger - pt stated she is feeling constant stimulation from the waist down. The pt stated it hurts in her head and down the back of her neck. She described a "stabbing pain" in her left hip down to her feet. Patient services (pss) asked if pt has had any traumas or falls recently. The pt stated no trauma but it seems like when they got "the 5g network" installed in their area - pt stated it feels like the ins kicked on after that event. The pt stated she lost the hand held programmer. The pt does not have an hcp anymore. The pt was asking if a local rep could check the ins.   the patient was redirected to their healthcare provider to further address the issue and an email was sent to the local field reps regarding pt call.
 
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Brand NameRESTORE ULTRA
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 Key12229322
MDR Text Key263577751
Report Number3004209178-2021-11422
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
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2008
Device Model Number37712
Device Catalogue Number37712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2007
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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