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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); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2019
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 ¿did not enter midway¿ when reinserting the stylet while the lead was in the patient¿s body. The stylet was removed and inserted several times, but the issue was not improved. The stylet was ultimately replaced with a stylet from a lead revision kit and the issue was resolved. It was noted that ¿only the stylet¿ was replaced at the time of the event and that the lead revision kit did not include the lead. The physician observed the cause of the issue to be the product and noted that it felt like the lead stylet was bent more than usual. It was stated that ¿it felt that the lead itself was caught when inserting the stylet. ¿ there were no surgical interventions planned or performed and the spinal canal stenosis 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 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9113406
MDR Text Key162680579
Report Number2649622-2019-17204
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/11/2019
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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