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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 Hematoma (1884); Muscle Weakness (1967); Paralysis (1997); Insufficient Information (4580)
Event Date 01/30/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead. Product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 05-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 patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that several hours after surgery a hematoma formed causing an onset of paralysis in bilateral lower extremities. Leg weakness and sleepy sensation. The cause was unknown. Paddle lead was removed. 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 Key11268006
MDR Text Key229916837
Report Number2649622-2021-02083
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/22/2020
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: 02/02/2021 Patient Sequence Number: 1
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