BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4132897 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18096
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WENT TO LIE DOWN, SHE FELT A SHOCKING SENSATION. WHEN SHE WOULD LIE DOWN OR GO TO BED IT WOULD VIBRATE. IT WAS REPORTED AS A SHOCKING OR JOLTING SENSATION. THE PATIENT COULDN¿T SLEEP AND THOUGHT SHE WAS GOING THROUGH A SHOCK AND WAS VIBRATING AND HER HAIR WAS STANDING UP ON HER HEAD. FOLLOW-UP REPORTED THAT THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. THE EVENT CAUSE WAS NOT DETERMINED AND REPROGRAMMING WAS STATED TO BE NEEDED. IT WAS STATED THAT THE PATIENT DID NOT LOSE THERAPEUTIC EFFECT OR STIMULATION. THE PATIENT WAS NOTED TO HAVE NOT RECOVERED AND THE SYMPTOM/ISSUE WAS ONGOING. FURTHER FOLLOW-UP WAS ATTEMPTED WITH THE PATIENT TO DETERMINE IF ANY ADDITIONAL INTERVENTION WAS PERFORMED AND TO DETERMINE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613256 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR