BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3003894 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03699
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 27, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HEALTH CARE PROFESSIONAL HAD NOT SEEN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE WHEN SHE LAY ON HER BACK. THE REPORTER STATED THAT THE PATIENT TRIED TO TURN THE DEVICE DOWN SO SHE COULD SLEEP ON HER BACK BUT THE PATIENT PROGRAMMER WOULDN'T LET HER. IT WAS NOTED THAT THE PATIENT CHANGED THE BATTERIES IN THE PATIENT PROGRAMMER AND ALSO PUT THE ANTENNA OVER THE IMPLANT. IT WAS REPORTED THAT THE PATIENT HAD A FALL IN (B)(6) 2012 BUT THE PATIENT WAS EXPERIENCING THE SHOCKING PRIOR TO THE FALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107609 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR