BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4131813 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18054
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 3, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A ¿PROBLEM¿ WITH THE SPINAL CORD STIMULATOR (SCS) THAT WAS IN HER HIP. IT BOTHERED THE PATIENT ¿REAL BAD.¿ THE PATIENT STATED SOMETIMES WHEN SHE WAS ¿CHARGING IT OR SOMETIMES IT FEELS REAL HOT BACK THERE.¿ THE PATIENT WOULD LAY ON TOP OF THE ANTENNA WHEN SHE RECHARGED AND DID NOT USE THE RECHARGING BELT. THE PATIENT NOTICED IT BEING ¿HOT BACK THERE¿ AND IT BEING BOTHERSOME JUST IN THE LAST FEW/COUPLE OF MONTHS. THE PATIENT WANTED TO KNOW IF THAT WAS NORMAL. LATER, THERE WAS A REPORTED 50% OR GREATER SYMPTOM REDUCTION. THE COMPONENTS INVOLVED IN THE EVENT WERE THE LEAD, EXTENSION AND PROGRAMMER. THE PATIENT OUTCOME WAS RECOVERY WITHOUT PERMANENT IMPAIRMENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612725 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR