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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); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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: 17-dec-2024, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 25-nov-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer representative reported that the patient had imaging completed by her physician that indicates a lead migration.  when asked if the patient had fallen or trip she denied both; however, stated that she has a "rambunctious" larger dog that she was tending to after an injury after her implant was completed. The patient will be scheduled for a reprogramming. The health care professional has no further information regarding this event at this time. The issue has not yet been resolved. No surgical intervention has occurred, and at this time, it is unknown if one is planned.
 
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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 Key11900736
MDR Text Key253169848
Report Number3004209178-2021-08496
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2022
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 Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/11/2021
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: 05/28/2021 Patient Sequence Number: 1
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