BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3677606 · Received March 13, 2014

    Report

    Report Number
    3004209178-2014-04417
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Report Date
    February 21, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377760, LOT# V010176, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 355029, LOT# N0041794, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ¿MINOR ELECTRICAL SHOCK.¿ IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿POSSIBLY SHORTING OUT AND CAUSING VERY MINOR ELECTRICAL SHOCKS.¿ IT WAS NOTED THAT THE PATIENT CONTINUED TO GET ¿MINOR SHOCKS¿ WHEN DRINKING SODA OUT OF A GLASS, BUT DID NOT NOTICE IT IF HE USED A STRAW. IT WAS NOTED THAT THIS WAS ¿ANNOYING¿ TO THE PATIENT. IT WAS NOTED THAT THIS BEGAN ABOUT A YEAR PRIOR TO THE REPORT. 2014-02-26: CRTS (B)(4) (CON): ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WAS ¿GETTING A LITTLE BITTY SHOCK EVERY TIME HIS LIPS TOUCHED THE DRINK.¿ IT WAS NOTED THAT THE PATIENT MENTIONED THIS TO THE HEALTH CARE PROFESSIONAL (HCP) AND WAS TOLD THAT ¿THIS COULDN¿T BE.¿ IT WAS NOTED THAT WHEN THE PATIENT¿S DEVICE WAS OFF, HE STILL GOT THE SHOCK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WAS "GETTING A LITTLE BITTY SHOCK EVERY TIME HIS LIPS TOUCHED THE DRINK." IT WAS NOTED THAT THE PATIENT MENTIONED THIS TO THE HEALTH CARE PROFESSIONAL (HCP) AND WAS TOLD THAT "THIS COULDN'T BE." IT WAS NOTED THAT WHEN THE PATIENT'S DEVICE WAS OFF, HE STILL GOT THE SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150235 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR