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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 Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
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 via the health care provider regarding a patient with an implantable neurostimulator (ins). It was reported that the patient discussed with their doctor and he too felt and found the pocket too wide. The physician pointed out the risks of another surgery, smaller pocket. The patient has considered that. The patient experienced too much pain when sitting against something, a hard back chair, or passenger seat in the car. It went well for a while after the settings were changed, but the patient still has to search gently with their hand. When the patient gets get up in the morning the ins was at an angle, but if they have to get out at night to go to the toilet, it was also at an angle and goes straight again when they stand up. The charger/remote was on sound, but it doesn't give a sound when at 100%, so the patient has to check regularly how far along they are. The pat ient charges at the same time every day, usually 50%, or sometimes 40%. There are days that it charges super fast about 20-30 minutes, but also happens regularly again that it can't find a device. The last few weeks the patient often stops at 90% and leave it like that, lying on the ins just hurts. Yesterday the patient received a message they have never had before, was lying down for about 15 minutes, while he indicated: charging excellent. On (b)(6) 2021 a conclusion was made that there was no dysfunction of the ins or charger but rather mistrust in the system. The patient has had other notifications. A picture showed that the ins was almost completely empty, screen 50, and could not start charging right away but that the current first drips into it. It was noted that the patient had been charging for 15 minutes with a charging quality of excellent. The patient has a consultation on (b)(6) 2021 to discuss revision of the pocket but would like to be sure there was nothing technically wrong with the ins.
 
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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 Key11703687
MDR Text Key247349896
Report Number2182207-2021-00672
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
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 Received04/07/2021
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: 04/21/2021 Patient Sequence Number: 1
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