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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 Problems Delayed Charge Time (2586); Battery Problem (2885)
Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Distress (2329)
Event Date 12/15/2010
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 failed back surgery syndrome. The patient reported that he was living in a nightmare because some days the numbing from the ins stayed in the spine and takes care of his pain but this morning he woke up in pain and couldn¿t find his patient programmer (pp) to adjust his stimulation. The pp is lost. The patient reported that he¿s been so stressed out looking all over for the pp that his head was spinning and he had a headache. The patient reported that due to his excessive pain he was having trouble remembering things. The patient reported that charging the implant has been a bad dream for him because sometimes he used high settings and that drained the implant battery quickly and since his implant is located on his butt and charging the implant can be a long experience and some days he just can¿t sit down the recharger that long. The patient reported that because of this its really been an effort for him to keep his implant charged up. No further complications were reported.
 
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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
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8290649
MDR Text Key134586083
Report Number3004209178-2019-02082
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 01/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2011
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 Received01/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2010
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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