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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 PAIN RELIEF

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MPRI VECTRIS SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 977A260
Device Problems Difficult to Insert (1316); Positioning Problem (3009); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that unable to reinsert the stylet. The circumstances that led to the inability to reinsert the stylet was frequent removal and replacement of the stylet. The faulty lead was replaced. The issue was resolved at the time of report. No symptoms were reported.
 
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Brand NameVECTRIS SURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11118676
MDR Text Key225328544
Report Number2649622-2021-00187
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number977A260
Device Catalogue Number977A260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/17/2020
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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