BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4241644 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21269
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE A SHOCKING OR JOLTING SENSATION ABOUT FIVE MONTHS PRIOR TO THE CALL. NO FALLS/TRAUMA WAS REPORTED, BUT THE PATIENT DID HIT A FEW POTHOLES WHILE DRIVING. THE PATIENT REPORTED THE SYMPTOMS ALSO OCCURRED "THE OTHER DAY" AND "THE OTHER NIGHT". THE SHOCKING OR JOLTING WAS DESCRIBED AS SHOCK WAVES IN THE SHOULDER AND EVERYWHERE ELSE BY THE PATIENT. INITIALLY, THE PATIENT DID NOT HAVE A PATIENT PROGRAMMER AND COULD NOT ADJUST, BUT WHEN THEY TURNED OFF THE THERAPY THE SHOCKING SUBSIDED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722754 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR