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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 Problems Difficult to Insert (1316); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider). The physician reported the lead n ot moving through the needle as freely as it should. He tried a different needle and the problem continued. There was an allegation that the lead may be defective. A new lead was opened and it worked fine. The lead was discarded before the manufacturer representative had a chance to tell them to hold it for return.

 
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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 Key12361730
MDR Text Key267938235
Report Number2649622-2021-17247
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,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2021
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/01/2021
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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