BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2936004 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01148
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    March 5, 2012
    Report Date
    January 31, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N151863, IMPLANTED: (B)(6) 2009. EXPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXAMINATION/PALPATION ON (B)(6) 2012 REVEALED THAT THE DEVICE MADE THE PATIENT "NERVOUS" AND SHE WAS "ANXIOUS" USING IT. THE ENTIRE SYSTEM WAS EXPLANTED AND THE PATIENT RECOVERED WITHOUT SEQUELA THAT SAME DAY. IT WAS NOTED THAT IT WAS POSSIBLY RELATED TO DEVICE OR THERAPY BUT UNLIKELY RELATED TO IMPLANT PROCEDURE. SEVERITY OF THE EVENT WAS NOTED AS MILD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL INDICATED THAT THE ETIOLOGY WAS POSSIBLY RELATED TO THE DEVICE/THERAPY, SPECIFICALLY TO THE NEUROSTIMULATOR. THE ETIOLOGY WAS UNLIKELY RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL PROVIDED THE PATIENT'S BASELINE WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41044 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention