BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3013078 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03978
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748966 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 748966 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 3887-33 LOT# J0123293V, IMPLANTED: 2001 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 3887-33 LOT# J0123293V, IMPLANTED: 2001 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD FLUID AT THE POCKET SITE. FLUID WAS DRAWN TO BE TESTED, AND NO INFECTION WAS FOUND. IT WAS NOTED THAT IT MIGHT HAVE BEEN DUE TO "SOFT TISSUE." IT WAS ALSO NOTED THERE WAS "A LOT OF SCAR TISSUE BUILDUP FROM THE 3 PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTS."IT WAS STATED THE PHYSICIAN MOVED THE INS TO THE LEFT FRONT SIDE OF THE PATIENT'S BODY. IT WAS UNCLEAR WHEN THE INS WAS MOVED, AND IF THE FLUID RELATED TO THE SCAR TISSUE. FLUID AT THE POCKET SITE WAS ALSO REPORTED UNDER MANUFACTURER REPORT# 3004209178-2013-03973.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS STATED THAT WHEN THEY PUT THE FOURTH ONE IN, THEY PUT IT BACK ON THE LEFT SIDE JUST ABOVE THE BUTTOCKS, BUT THEN IT WAS REALLY PAINFUL SO THEY MOVED IT AROUND TO THE FRONT SIDE ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115013 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention