BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4240969 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21240
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N245038, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N245038, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONNECTOR PIN HAD BROKEN ¿ABOUT A MONTH AND A HALF AGO.¿ ADDITIONALLY, THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WASN¿T CHARGING. UPON PRODUCT RETURN, ANALYSIS FOUND THAT THE CONNECTOR HAD BROKEN. C300. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SENT A NEW AC POWER SUPPLY, THIS WAS IN AUGUST 2014. IT WAS NOTED THAT THE AC POWER SUPPLY DID NOT RESOLVE HER ISSUE. SHE WAS STILL UNABLE TO CHARGE AND NOTED THAT THE ENTIRE ISSUE STARTED A MONTH BEFORE SHE CALLED IN AUGUST. THE INSR WAS SHOWING REPOSITION ANTENNA AND LAST FELT STIMULATION WHEN SHE CALLED IN AUGUST. THEY COULD NOT REMEMBER THE LAST TIME SHE HAD A SUCCESSFUL RECHARGER. THE PATIENT PROGRAMMER SCREEN WAS BLANK. THEY DID NOT HAVE NEW BATTERIES TO TRY AT THE TIME OF THE CALL. THE PATIENT CALLED BACK IN AND NOTED THAT SHE DID GET NEW BATTERIES FOR HER PATIENT PROGRAMMER AND THE PATIENT WAS DIRECTED TO CONTACT HER PHYSICIAN FOR A RESTART. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    (B)(4). INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT CONNECTOR PIN HAD BROKEN ABOUT A MONTH AND A HALF AGO. ADDITIONALLY, THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WASN'T CHARGING. UPON PRODUCT RETURN, ANALYSIS FOUND THAT THE CONNECTOR HAD BROKEN. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SENT A NEW AC POWER SUPPLY, THIS WAS IN (B)(6) 2014. IT WAS NOTED THAT THE AC POWER SUPPLY DID NOT RESOLVE HER ISSUE. SHE WAS STILL UNABLE TO CHARGE AND NOTED THAT THE ENTIRE ISSUE STARTED A MONTH BEFORE SHE CALLED IN (B)(6). THE INSR WAS SHOWING REPOSITION ANTENNA AND LAST FELT STIMULATION WHEN SHE CALLED IN (B)(6). THEY COULD NOT REMEMBER THE LAST TIME SHE HAD A SUCCESSFUL RECHARGER. THE PATIENT PROGRAMMER SCREEN WAS BLANK. THEY DID NOT HAVE NEW BATTERIES TO TRY AT THE TIME OF THE CALL. THE PATIENT CALLED BACK IN AND NOTED THAT SHE DID GET NEW BATTERIES FOR HER PATIENT PROGRAMMER AND THE PATIENT WAS DIRECTED TO CONTACT HER PHYSICIAN FOR A RESTART. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722455 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 00060 YR