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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97725
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  Injury  
Manufacturer Narrative

Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(6), ubd: 12-jan-2025, 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). It was reported that the patient had an epidural abscess after trial and the trial leads were removed. Additional information was received. The manufacturer representative (rep) reported that it was unknown if the trial implant was causal with respect to the epidural abscess. The rep also provided the trial external neurostimulator serial number and the dates of the trials and event date. The rep reports that the trial started on (b)(6) 2021 and leads were pulled on (b)(6) 2021.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11793302
MDR Text Key249681411
Report Number2182207-2021-00770
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,Followup
Report Date 05/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97725
Device Catalogue Number97725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/22/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/07/2021 Patient Sequence Number: 1
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