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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 97715
Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 14-dec-2024, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 11-dec-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 (rep) who was implanted with an implantable neurostimulator (ins) for spinal pain. The patient stated that his pain has gotten worse.  the patient was hit in the back by a door and that his pain has increased since then.  new x-rays were taken and the patient has had lead migration. The rep attempted to reprogram based on the new images and was able to get good perception over the patients areas of pain. The issue was resolved.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
ceiba norte industrial park
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
ceiba norte industrial park
villalba PR 00766
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11761311
MDR Text Key266440456
Report Number3004209178-2021-07078
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2021
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 Received08/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/30/2020
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: 05/03/2021 Patient Sequence Number: 1
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