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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number NEU_INS_STIMULATOR
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Discomfort (2330); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative
Literature citation: graham dt, lambert m, mirzadeh z, ponce fa. Factors contributing to spinal cord stimulation outcomes for chronic pain. Neuromodulation. 2021. Doi: 10. 1111/ner. 13515 literature summary: the goal of the study was to identify factors that affect patient outcome with regard to spinal cord stimulation (scs). The authors concluded that patient outcome was associated with diagnosis, postimplantation falls, and device manufacturer. Further investigation is recommended to confirm associations through prospective studies that can more accurately quantify patient outcome over longer periods. Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the sex of the majority of the patients reported in the article as specific patients could not be identified. Date of event: please note this date is based off of the article¿s publication date as specific event dates were not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Other applicable components are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: asku, udi#: asku. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Reported events: 1. 5 spinal cord stimulation (scs) devices were explanted due to discomfort. 2. 3 scs devices were explanted due to adverse effects. 3. 3 scs devices were explanted due to infection. 4. 2 scs devices were explanted due to complications. 5. 1 scs device was explanted due to hardware failure. Additional information received from the article¿s author of correspondence noted that while there were devices involved in the reported cohort that were produced by the reporting manufacturer, the patient database was identified and as such no further device or event details could be provided. No further complications were reported or anticipated.
 
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Brand NameIMPLANTABLE NEUROSTIMULATOR
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12712106
MDR Text Key278801740
Report Number2182207-2021-01882
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device Lot NumberUNKNOWN
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 Received10/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/28/2021 Patient Sequence Number: 1
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