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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 97714
Device Problems High impedance (1291); Unintended Collision (1429)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)
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 patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that there was poor stimulation in left lower back and too much stimulation in lower legs.  patient reports multiple falls without significant injury over the last several months. She is unable to recall details of the events, but denies any er/hospitalizations visits due to falls.  patient reports she had x-ray of back in april, but cs did not have access to x-ray report or film. The rep interrogated device. High impedance >10000 found on ¿0¿ contact. Was able to change contact reference and verified 1-7 were wnl. Gave patient three new programs and successfully targeted painful area in left side of back. However it was noted issue not resolved.

 
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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 Key12202450
MDR Text Key262639535
Report Number2649622-2021-14630
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2018
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/19/2018
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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