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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 PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Electric Shock (2554); Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. It was reported that the device was turning itself on at random. It was a device issue. Continuous shocking and burning paining internally throughout spine and brain. The cause was not determined. No one would help, they kept passing the buck. Patient finally requested removal. The device was removed completely. Patient feels they left parts of it still in the patient because they still feel the burning and shocking. There is nerve damage between shoulder blades concurrent with leads shocking muscles. The issues were not resolved. Event date was provided as around 9 months/year ago. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient's implantable neurostimulator (ins) for failed back surgery syndrome and non-malignant pain. Information was reported that the caller is from the er department, and wanted to discuss a "box" that is shocking the patient. The box which could not be described was used by the patient's son and was shocking the patient from across the room. The caller also indicated the patient has chest pain. The caller did not know if the patient has their patient programmer to turn off the ins, and then stated the patient has not used their stimulation for years. An overdischarged was suspected. It was discussed that the shocking would not be related to the ins unless the physical components were agitating a nerve. Troubleshooting could not be done due to lack of access to product. No further complications were reported. No additional patient symptoms were reported.
 
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Brand NameRESTORE SENSOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9197371
MDR Text Key167555016
Report Number3004209178-2019-19743
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,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2013
Device Model Number37714
Device Catalogue Number37714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/14/2013
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: 10/16/2019 Patient Sequence Number: 1
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