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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURO - VILLALBA VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

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NEURO - VILLALBA VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 977A290
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problems Pain (1994); Loss of consciousness (2418)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 97712, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. (b)(4).
 
Event Description
A patient who had an implanted neurostimulator (ins) for other and non-malignant pain reported on (b)(6) 2016 that they thought the permanent implant would be just like the first trial, with the leads like "railroad tracks". However, when they woke up from surgery, they only had two electrodes on the back of their skull where the occipital nerve is. It was noted that there was a "blue plastic connector square" where the cables connect in their neck, and a second connector in their mid-back area. It was also reported that the electrode on one side of their head was moving quite a bit, and the ins was also moving quite a bit in their hip. It was stated that the patient would black out if they turned their head or lifted their arms. This had been occurring once every other week since implant. The patient stated that they had pre-existing conditions including a blood clotting disorder, strokes, several genetic disorders, they "ultra-metabolizes" medications, goes into withdrawal, and had tried marijuana for nausea. Follow up efforts have been initiated to determine what steps had been taken to resolve the ins movement, lead movement, pain, and blacking out issues. A supplemental report will be submitted if additional information is received.
 
Event Description
Additional information received reported every once in a while, the patient blacked out if she turned her head or lifted her arms. This issue began after the stimulator was implanted and was due to the stimulator. The patient noted that this had been happening once every other week since implant. A supplemental report will be submitted if additional information is received.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. It was reported that the spinal stimulator was put in incorrectly. The patient had it removed by another doctor.
 
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Brand NameVECTRIS SURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
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 Key5383248
MDR Text Key36526681
Report Number6000153-2016-00181
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2019
Device Model Number977A290
Device Catalogue Number977A290
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 Received06/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/09/2015
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: 01/21/2016 Patient Sequence Number: 1
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