BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3024138 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04312
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-56, LOT # V369178, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V398029, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37082-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DISCOVERED THAT THE PATIENT HAD CELLULITIS AT THE IPG SITE ON (B)(6) 2013. THE IPG WAS REMOVED AND IT WAS REPORTED THAT THERE WAS NO HOSPITALIZATION AND NO INJURY. FOR INFORMATION REGARDING COMPONENTS THAT REMAINED IMPLANTED, SEE MFR. REP. # 3004209178-2013-03388.

    Description of Event or Problem · 1

    CELLULITIS WAS DISCOVERED (B)(6) 2011, NOT (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127203 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention