BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4121804 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17797
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    July 15, 2014
    Report Date
    September 2, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA09N88, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA0BNAS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97791, LOT# N412428, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS TAKING A LONG TIME TO RECHARGE. THE PATIENT HAD A MEETING PLANNED FOR TROUBLESHOOTING/BEST PRACTICES ON (B)(6) 2014. IT TOOK THE PATIENT 1-2 DAYS TO CHARGE. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS AT 50% WHEN SHE WAS RECHARGING AND SHE HAD 6-7 COUPLING BARS. PATIENT WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2014 AND HAD 6/8 COUPLING BARS WHEN RECHARGING. IT WAS NOTED THAT WHEN INTERROGATING THE SYSTEM THE PATIENT WAS SHOWING RECHARGING .7 TO 1.6 HOUR RECHARGING SESSIONS. THE PATIENT WAS EDUCATED ON RECHARGING AND GIVEN STICK TABS TO HELP WITH COUPLING AND RECHARGING WHEN SHE HAD TO BE ACTIVE. THE PATIENT HAD NOT FULLY RECHARGED THE DEVICE ACCORDING TO THE DIARY. THE PATIENT DID UNDERSTAND HOW TO RECHARGE. THE PATIENT HAD SENSOR ACTIVATED FOR THIS GROUP. THE PATIENT WAS FRUSTRATED AT THE POSITION OF THE INS AND HAD STATED THAT IT CAUSED IRRITATION AND SAT IN AN IRRITATING POSITION WHEN SITTING. PATIENT WAS NOT ALLERGIC TO TAPE. PATIENT WAS GETTING STIMULATION ON ALL AREAS OF PAIN. PATIENT WAS ABLE TO CHARGE NORMALLY AND WAS RECEIVING EFFECTIVE THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. THE ACTION REQUIRED AS A RESULT OF THE EVENT INCLUDED REVISION. THE PATIENT COMPLAINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNCOMFORTABLE SO THE DOCTOR RELOCATED THE GENERATOR TO THE RIGHT ABDOMEN. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT INCLUDED ALIVE WITH NO INJURY. THERE WAS NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602098 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 00027 YR