BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3022032 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04266
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37702 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37742 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AGITATED. THE PATIENT WAS UNCOMFORTABLE BECAUSE THEY HAD 2 BATTERIES IN THEIR HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF STIMULATION. IT WAS FURTHER REPORTED THAT THE PATIENT LAST FELT STIMULATION IN (B)(6) 2012. THE PATIENT STATED THAT HE FELT THE DEVICE WAS "DEFECTIVE" AND WISHED TO HAVE IT EXPLANTED. THE PATIENT WAS REDIRECTED TO HIS HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124469 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1