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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MPRI VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 977A260
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the stylet could not be fully inserted into the lead after several insertions and removals from the lead. The stylet was wetted with saline to make it slippery and the electrode region was touched from the outside and tried to advance it to the depths, but the stylet did not fit. It was noted that both the straight and bent stylets could not be inserted. The physician¿s observation about causality was asked, but unknown. A new lead kit was opened and used as a result of the event and the issue was resolved. The lead was never implanted. There were no surgical interventions planned or performed and the chronic pain patient was alive with no injury at the time of report. No complications were reported or anticipated.

 
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Brand NameVECTRIS SURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12173184
MDR Text Key261702042
Report Number2649622-2021-14267
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number977A260
Device Catalogue Number977A260
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/03/2021
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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