BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3502459 · Received December 5, 2013

    Report

    Report Number
    3004209178-2013-22025
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    November 21, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# VA02J9H, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V780541, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA00P29, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A STOMACH ACHE WITHIN 1-2 HOURS OF TURNING STIMULATION ON. THE PATIENT EXPERIENCED NAUSEA AND VOMITING ON A DAILY BASIS AFTER INGESTING FOOD. IT WAS REPORTED THE PATIENT¿S STOMACH ACHE WOULD GO AWAY AFTER A WHILE AFTER TURNING THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. THE PATIENT FELT THE STOMACH ACHE MAY BE RELATED TO STIMULATION, AND COULD SEE HOW IT COULD TRIGGER THE STOMACH ACHE BECAUSE OF THE LOCATION OF THE LEAD. HOWEVER, IT WAS REPORTED THAT THE OVERALL STIMULATION COVERED THE PATIENT¿S NEEDS, ALLOWED HIM TO BE AN ACTIVE PERSON, AND THAT THERAPY WORKED GREAT FOR HIM. IT WAS FURTHER REPORTED THE PATIENT FELL AROUND (B)(6) 2013 WHILE CLEANING CARPETS AND SYMPTOMS BEGAN AFTER THAT. THE PATIENTS BACK WAS REPORTED TO BE A LITTLE SORE FOR 1-2 WEEKS, BUT HE HASN¿T HAD ANY PROBLEMS SINCE. IT WAS REPORTED THE PATIENT¿S FALLS HAVE REDUCED SIGNIFICANTLY SINCE HE WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CANCELLED HIS APPOINTMENT WITH THE MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631861 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 00056 YR