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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/15/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a160, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 977a160, serial/lot #: (b)(4), ubd: 10-apr-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that there were signs/symptoms of infection at lead site. No known environmental/external/patient factors were reported. The site was assessed by the patient's doctor on (b)(6) 2021. The system was explanted on (b)(6) 2021. The plan was to reimplant at a later date once there were no signs of infection. The patient was prescribed antibiotics. The issue was resolved at the time of the event.
 
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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 Key12340098
MDR Text Key267217973
Report Number2649622-2021-16875
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,health
Reporter Occupation
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/22/2021
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: 08/18/2021 Patient Sequence Number: 1
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