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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 PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Date of event was reported as (b)(6) 2016. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from the patient reported that they were without stimulation from their implantable neurostimulator (ins) and was in a lot of pain. They stated had not been able to use the programmer to adjust the stimulation so they were in a lot of pain from the waist down (ins was implanted for this pain). The patient also reported they had nerve damage, pain in their ears/arms and did not take any pain medications. The indication for use for the implanted device was noted as non-malignant pain. There were no further details, troubleshooting, interventions, or an outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be submitted.
 
Event Description
Additional information received from the consumer reported their healthcare provider (hcp) wouldn't give them the "only pill that worked. " the consumer further reported the steps taken to resolve their pain issue was getting a new remote for "the upper but still need a cable. " the pain from the waist down was not resolved since it still hurt, "but the machine helped a lot, and i still have pain all through my body," as well as nerve damage and scar tissue.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESTORE ULTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5744521
MDR Text Key102099053
Report Number3004209178-2016-12775
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,Followup,Followup
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/14/2014
Device Model Number37712
Device Catalogue Number37712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/21/2013
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: 06/23/2016 Patient Sequence Number: 1
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