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U.S. Department of Health and Human Services

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

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MPRI INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Spinal Cord Injury (2432)
Event Date 05/03/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 977c165, serial# (b)(4). Implanted: (b)(6) 2021, explanted: (b)(6) 2021 product type: lead. Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 17-oct-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient had thoracic cord compression. The patient had urinary incontinence. It was unknown if there were any contributing factors that led to the reported issue. It was reported that the patient had an mri. The lead was explanted due to the compression and it was reported that the issue was resolved.

 
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Brand NameINTELLIS
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 Key11803362
MDR Text Key249952597
Report Number2649622-2021-09379
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
Reporter Occupation
Type of Report Initial
Report Date 05/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/17/2021
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: 05/10/2021 Patient Sequence Number: 1
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