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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 12/23/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the physician via the manufacturer representative. It was reported that the lead model and lot number was asked but unknown. The physician clarified that no replacement of the ins occurred. The patient experienced a loss of therapy. The lead was defective and was replaced. There was no data available regarding the impedance measurements prior to the replacement. After the replacement, the patient profited from the therapy again. It was indicated that the lead should have been returned but the status was unknown. The ins had not been returned.
 
Manufacturer Narrative
Report source was updated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. Foreign: (b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health insurance source via a manufacturer representative regarding a patient implanted with an implantable neurostimulator (ins). It was reported the patient had problems with the therapy. The clinician indicated replacement. During replacement of the neurostimulator, problems with the lead were determined. It was unknown if there were any environmental/extern al/patient factors that may have led or contributed to the issue. It was unknown if any diagnostics or troubleshooting was performed. The interventions taken to replace the issue included replacement of the lead and ins. The issue was resolved at the time of the report. No further details were known. A defective lead was noted; however, there was also a conflicting report that it was unknown if the lead was defective. It was unknown if the ins had to be replaced due to battery depletion or due to another reason. There was no further patient complication associated with the event.
 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
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 Key7153104
MDR Text Key102634908
Report Number3007566237-2017-05335
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
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: 12/28/2017 Patient Sequence Number: 1
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