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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 977A275
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  Malfunction  
Manufacturer Narrative

Analysis of the lead found that the stylet coil was stretched due to a procedural non-conformance. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The health care professional reported via a manufacturer representative that the lead was attempted to be implanted. However, when the stylets were attempted to be changed out, neither (straight or curved) would thread all the way back to the lead tip. Both stylets were stuck at the 5th contact. This was during the procedure, so a different lead was used and two leads were ultimately placed.  lead was removed from the body to attempt to thread the stylets. Neither stylet would thread outside of the body either.

 
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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 Key11960967
MDR Text Key256257094
Report Number2649622-2021-11414
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 06/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number977A275
Device Catalogue Number977A275
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/13/2021
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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