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

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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, 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 Key: 12712106
• MDR Text Key: 278801740
• Report Number: 2182207-2021-01882
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR