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U.S. Department of Health and Human Services

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

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MPRI SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 977D260
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that during the procedure, the physician was trying to access epidural space and patient started to bleed. When a lateral was taken, there was dark areas along spine that were not present on the prior image. The physician aborted the procedure. No lead was ever attempted to implant-it was only the needle from the trial lead kit. The patient was being sent to the emergency room for monitoring. It is unknown if the issue resolved.

 
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Brand NameSURESCAN
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 Key11605072
MDR Text Key243472746
Report Number2649622-2021-06318
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,Followup
Report Date 04/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number977D260
Device Catalogue Number977D260
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 Received04/02/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/28/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/01/2021 Patient Sequence Number: 1
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