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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37711
Device Problems No Device Output (1435); Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problems Inflammation (1932); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id: 37742, serial#: (b)(4), product type: programmer, patient. 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
A consumer reported the patient physically damaged and broke the patient programmer (pp) so it wouldn¿t work and the buttons were broken. No out of box failure was reported. It was further reported starting three months ago the patient was seeing the ¿call your doctor¿ error message on the recharger every time they tried to charge, which they were still able to do, but neither the programmer or recharger were able to turn the implant on. It was noted the patient had been out of the country for some time and hadn¿t used their device, but because their implantable neurostimulator (ins) didn¿t work (they couldn¿t turn it on) they started having leg and back pain. Due to this they were put on more pain medications to control the back pain because they didn¿t have the ins to help with it which caused leg wounds, kidney issues/injury, and inflammation resulting in them being put in the hospital where they were trying to cut down the pain medications because they were causing the inflammation and kidney issues. It was reviewed with the consumer that due to the time line the patient may be seeing the end of service (eos) message, but this was unable to be confirmed. It was noted the manufacturer¿s representative (rep) was called but they couldn¿t do anything because the ins wasn¿t charged and they were redirected to their healthcare provider (hcp). Relevant medical history includes degenerative disc disease/herniated disc pain.
 
Manufacturer Narrative
(b)(4). The device was returned, but was not analyzed. The patient programmer was scrapped due to corroded digital boards.
 
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Brand NameRESTORE
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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6236662
MDR Text Key102630951
Report Number3004209178-2017-00527
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
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2008
Device Model Number37711
Device Catalogue Number37711
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 Received02/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2007
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: 01/10/2017 Patient Sequence Number: 1
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