BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4132567 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18083
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97792, LOT# N364196, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD NO CONCERNS WITH THEIR DEVICE THERAPY. THE PATIENT ALSO REPORTED THAT THEY RECEIVED ASSISTANCE FROM THEIR DOCTOR/MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT NOTED THAT THEY WILL BE MOVING TO ECUADOR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A WET, DROPPED, OR CRUSHED UNIT. THE PATIENT REPORTED THAT THE GRAY WIRE WAS CUT IN 2 PLACES. THE PATIENT NOTICED THIS ON SATURDAY MORNING. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE PATIENT HAD A DAMAGED RECHARGE ANTENNA. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EMPTY. IT WAS RECOMMENDED THAT THE PATIENT CHARGE HIS INS ONCE HE RECEIVES THE NEW IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) ANTENNA. THE PATIENT THOUGHT THAT THE INS WAS DAMAGED. THE PATIENT STATED THAT THE INS WAS HIT HARD. THE PATIENT WAS INFORMED THAT THE INS HAD TO BE CHARGED IN ORDER TO INTERROGATE AND CHECK FOR ANY OTHER ISSUES. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611908 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 00062 YR