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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_ENS_STIMULATOR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
Other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type: screening device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer's representative and a consumer regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that after the patient's scs trial they had some pain and ended up going to the er. They noted that the er visit was long after the trial but it was unknown how long. The patient was found to have a spinal infection and had to have 3 level bone scrapped t12-l1 and now had nerve damage. The neurosurgeon didn't know if it was from the scs trial. The issue was noted as being resolved. No further complications reported.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type: screening. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer's representative. The representative didn't know what the cause of the nerve damage was and they noted that the patient was recovering. The issue occurred about 2 weeks after the trial. No further complications reported.
 
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Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8047221
MDR Text Key126423665
Report Number3007566237-2018-03252
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
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 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNEU_ENS_STIMULATOR
Device Catalogue NumberNEU_ENS_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 Received11/07/2018
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: 11/07/2018 Patient Sequence Number: 1
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