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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURO - VILLALBA INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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NEURO - VILLALBA INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems High impedance (1291); Unintended Collision (1429); Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical product: product id 39565-65; serial#: (b)(4); implanted: (b)(6) 2011. Product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that there were impedance issues on electrodes 0-7. Electrode 0 showed, "do not use" with no impedance measurement, and electrodes 1-7 showed an orange exclamation point and were labeled "avoid". The patient stepped down off a curb and their leg gave out. The patient said he fell and back hit the curb. The rep reprogrammed around the impedances. The issue was reportedly not resolved at the time of the report. It was asked, but unknown whether surgical intervention was planned. No symptoms were reported.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
Manufacturer (Section G)
NEURO - VILLALBA
call box 6001
villalba PR 00766
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10734015
MDR Text Key213015470
Report Number6000153-2020-00023
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 10/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2018
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/16/2017
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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