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U.S. Department of Health and Human Services

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

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MPRI SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 977D260
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  Malfunction  
Manufacturer Narrative

The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing. Analysis determined that foreign material was blocking the insertion of the stylet. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The healthcare provider (hcp) reported via the manufacturer representative that while changing out stylets they were unable to feed stylet into the lead. The hcp said he tried multiple stylets and they would not go all the way in. No external or patient factors were noted to have contributed to the issue. The hcp replaced the lead and the issue was resolved. There were no symptoms as no patient was involved.

 
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Brand NameSURESCAN
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 Key11970287
MDR Text Key255373578
Report Number2649622-2021-11525
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
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 06/09/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number977D260
Device Catalogue Number977D260
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2020
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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