BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2983560 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03180
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97792, LOT# N357580, 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. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD MIGRATION. IT WAS STATED THAT THE INJEX ANCHOR CAUSED THE LEAD TO MIGRATE WHEN DEPLOYED. THERE WAS NO ACTION TAKEN. IT WAS ALSO STATED THAT WHEN THE INJEX ANCHOR WAS DEPLOYED, IT APPEARED TO "CINCH LEAD AND PULL IT DOWN TOWARD ONE CONTACT". IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. FURTHER INFORMATION HAS BEEN REQUESTED AND IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86320 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 00009 DA