BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4243948 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21348
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 20, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT STATED, ¿LAST NIGHT I NOTICED MY STIMULATOR WAS GOING IN AND OUT AND I CHECKED IT AND IT SAID MY BATTERIES IS FULL BUT NOW I CAN¿T CUT MY DEVICE ON WITH THE RECHARGER OR THE MYSTIM.¿ THE PATIENT ALSO STATED SHE WAS LOOKING AT THE RECHARGER BATTERY LEVEL, WHICH WAS FULL, BUT WHEN SHE LOOKED AT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LEVEL IT WAS ¿ONLY A QUARTER FULL.¿ PATIENT SERVICES REVIEWED WITH THE PATIENT THAT SHE MUST RECHARGE THE INS AND THAT THE PATIENT WOULD NOT BE ABLE TO TURN STIMULATION BACK ON UNTIL HER INS BATTERY LEVEL IS AT 25 PERCENT OR MORE FULL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR 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
    725552 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR