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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NEU_INS_STIMULATOR
Event Date 03/16/2012
Event Type  Malfunction  
Manufacturer Narrative

Product id 3998, lot # v133492, implanted: (b)(6) 2008, product type lead. Product id 37752, serial # (b)(4), product type recharger. Product id 37743, serial # (b)(4), product type programmer. Product id 37082-60, serial # (b)(4), implanted: (b)(6) 2008, product type extension.

 
Event Description

It was reported that on (b)(6) 2012 the patient was prying up a side rail on a coal car and something popped. The implantable neurostimulator (ins) quit working and coupling and communication could not be established. The patient could not feel stimulation. An overdischarge had occurred. The patient had not been able to communicate with the ins since (b)(6) 2012. The last time any stimulation was felt was (b)(6) 2012. The last successful recharging session was (b)(6) 2012. Antenna locate feature was unsuccessful in connecting. This was the first overdischarge for this ins. Patient outcome was not provided. Additional information has been requested, but was not available as of the date of this report.

 
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Brand NameUNKNOWN IMPLANTABLE NEUROSTIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 120
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55431
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431
7635263987
MDR Report Key2592479
Report Number3007566237-2012-01207
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/02/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Was Device Available For Evaluation? No
Date Manufacturer Received05/02/2012
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

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