BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3955837 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13494
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 2, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A FEW WEEKS AFTER IMPLANT, THE LEADS MALFUNCTIONED. THE PHYSICIAN TOOK CARE OF IT RIGHT AWAY. THE PHYSICIAN OPENED UP THE PATIENT AND FIXED THE LEADS. THE PATIENT STATED IT HURT BEING ON THE OPERATING TABLE. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT THE LEAD REVISION CONSISTED OF THE PHYSICIAN MOVING THE LEAD BACK INTO PLACE. THE CAUSE OF THE MIGRATION WAS NOT DETERMINED. THE PATIENT RECOVERED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434941 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention