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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 37714
Device Problems Failure to Deliver Energy (1211); Impedance Problem (2950); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
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 via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins). It was reported that the patient felt a sensation in his back after which he noticed loss of therapy. The rep ran an impedance check and electrodes 4-7 were out of range, 0-3 were within range on (b)(6) 2021. Only electrodes 0-3 were in use at the time of the event. Reprogramming was attempted on (b)(6) 2021. Stimulation was unable to be felt by the patient at max voltage output (10. 5 v). The patient stated that he usually ran the device around 10-10. 5 v, and that sometimes he would need to arch his back to feel the sensation. Patient had been very pleased with the therapy prior to loss of stimulation and concurrent loss of efficacy/relief. The healthcare provider (hcp) had consulted with the patient on (b)(6) 2021 regarding next steps. The patient and hcp are considering re-trialing the therapy in a different location and a possible lead and ins replacement.
 
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Brand NameRESTORE SENSOR
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 Key11844902
MDR Text Key251441581
Report Number3004209178-2021-07914
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 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2014
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2013
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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