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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems Therapy Delivered to Incorrect Body Area (1508); Charging Problem (2892); Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Pain (1994); Seroma (2069); Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for a back problem. It was reported that the there was a malfunctioning internal pain controlling device and there were problems. The patient has had +- 4 back operations the last 5 months, all done by the same doctor. From day 1 that they fitted the new battery to help the patient with their pain, they have had problems with it. First, it did not stimulate the correct places as required by the patient and as it was before. Second, the battery did not charge full from day 1. There were complications: constant back pain and left side constantly burning in lower back and left leg, constant pain in right side top leg. That the battery does not want to charge the way it's supposed to. It was recommended to have the doctor remove some of the liquid swelling by a needle. There was persistent pain in their bladder and kidney so the patient had to switch the ins off to stop the pain from last operation. The doctor thought it was the battery but the patient was constantly under pain. The second last operation in december, the patient started to feel the pain a day before they left the hospital. The ins was not working correctly.
 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11446335
MDR Text Key239365366
Report Number2182207-2021-00406
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/09/2021 Patient Sequence Number: 1
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