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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN TRIAL LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

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MEDTRONIC NEUROMODULATION UNKNOWN TRIAL LEAD STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 3874
Device Problems Bent (1059); Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the lead found the conductor was broken. It was noted that the distal end of the lead was bent at proximal edge of the #1 electrode sleeve. It was noted that the #1 conductor was broken at this location, 1 cm from the distal end. Analysis of the stylet found the wire was bent (new out of box).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the lead tip was bent at almost a 90 degree angle and 'you could see the silicone was separated from the lead. ' the health care provider did not want to try implanting the lead. It was also noted nothing happened to the package before it was opened. Follow up noted the 'defective' lead was never implanted and the patient had a successful trial with another lead.
 
Manufacturer Narrative
Concomitant products: product id neu_ens_stimulator, product type external neurostimulator; product id neu_stylet_acc, product type accessory. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.
 
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Brand NameUNKNOWN TRIAL LEAD
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key3070329
MDR Text Key101181214
Report Number3007566237-2013-01369
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,company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/05/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3874
Device Catalogue Number3874
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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