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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 Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2018
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) for unknown indications for use. It was reported that  per call received today (9/14/2021) from the patient, her old pain stim system was removed and replaced on (b)(6) 2018 because it was not working correctly. No patient symptoms were reported.
 
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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 Key12501218
MDR Text Key272580866
Report Number3004209178-2021-14133
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 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2010
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 Received09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/15/2009
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: 09/20/2021 Patient Sequence Number: 1
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