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U.S. Department of Health and Human Services

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

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MPRI INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97725
Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431)
Patient Problems Pain (1994); Dizziness (2194); Neck Pain (2433)
Event Date 07/27/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: screening device. Product id: 977d260, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: screening device. Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 26-may-2025, udi#: (b)(4). Product id: 977d260, serial/lot #: (b)(4), ubd: 27-may-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received via a manufacturer representative from a patient who started a trial of a spinal cord stimulation system on (b)(6) 2021. It was reported that on (b)(6) 2021, the patient experienced a change in stimulation to his right hand, pain and dizzi ness upon standing. The manufacturer representative met with the patient at the clinic on (b)(6) 2021 to attempt reprogramming; however, it was unsuccessful. The physician decided to pull the lead due to possible movement. He then replaced the lead. The patient had good results, but on 2021-jul-29, the patient had severe left sided neck pain described as sharp, shooting pains. The patient returned to the clinic on (b)(6) 2021. Impedances were checked, and they were okay. The clinic pulled the lead under fluoroscopy. The image showed some movement of the lead. These issues have been resolved.

 
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Brand NameINTELLIS
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 Key12281389
MDR Text Key265185873
Report Number2649622-2021-15790
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
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 08/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97725
Device Catalogue Number97725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/25/2021
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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