BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2656737 · Received July 16, 2012

    Report

    Report Number
    3004209178-2012-05660
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    July 23, 2012
    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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V163064, IMPLANTED (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3998, LOT# V080086V02, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION WHEN TURNING ON THE INTERNAL NEUROSTIMULATOR (INS) AFTER AN OVERDISCHARGE. INS WAS SUBSEQUENTLY TURNED OFF. THE PATIENT DID A PHYSICIAN MODE RECHARGE (PMR) AFTER NOT USING THE INS FOR 2 - 2.5 MONTHS AND CHARGED THE INS ALL NIGHT. IN THE MORNING THE PATIENT RECEIVED A SHOCK WHEN GOING TO TURN ON THE INS. THE PATIENT INDICATED SHE SAW THE STIMULATION WAS ON AND COULD CHANGE HER PROGRAMMING BUT DID NOT FEEL ANY STIMULATION SENSATION. THE INS WAS SHUT OFF AGAIN. TROUBLESHOOTING WAS DONE WITH THE PATIENT WHEREIN THE PATIENT WAS WALKED THROUGH A SUCCESSFUL PMR AND THE INS WAS TURNED ON. THE PATIENT FELT STIMULATION AT THE APPROPRIATE LEVEL AND LOCATION. THE ISSUE WAS RESOLVED AND THE PATIENT WAS DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ALLOWED HER IMPLANTABLE NEUROSTIMULATOR (INS) TO "DIE." THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE WHO "JUMP STARTED" HER INS AND DID ADDITIONAL PROGRAMMING. THE PATIENT WAS SATISFIED WITH THE RESULTS. NO ABNORMAL IMPEDANCES WERE MEASURED. NO SURGICAL INTERVENTION WAS REQUIRED. NO HOSPITALIZATION WAS REQUIRED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1