BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4277627 · Received November 25, 2014

    Report

    Report Number
    3004209178-2014-22196
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    November 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-29, LOT # N141220, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 39286-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A YEAR AFTER THE PATIENT¿S LEAD REVISION, THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD TO BE MOVED TO HER STOMACH. THE PATIENT WAS UNSURE IF THE INS WAS JUST MOVED TO HER STOMACH OR IF THEY EXCHANGED IT. AFTER THEY MOVED THE INS TO HER STOMACH, IT DID NOT TAKE LONG BEFORE THE INS STARTED POPPING OUT OF THE POCKET. THE PATIENT STATED THAT SHE COULD NOT REACH AND IT WOULD JUST POP OUT OF HER STOMACH. IT WAS NOTED THAT IT POPPED OUT ¿SEVERAL TIMES¿ AND THEY HAD TO PUT IT BACK TWICE, BUT THE PATIENT COULD NOT REMEMBER THE EXACT DATES. THE PATIENT STATED THAT SHE THEN STARTED GAINING SOME WEIGHT AND THAT KEPT IT IN THE SECOND TIME, BUT SHE LOST ALL MUSCLE TONE IN HER STOMACH ENTIRELY. IT WAS NOTED THAT THE WEIGHT GAIN AND MUSCLE TONE LOSS HAPPENED NOT LONG AFTER THEY MOVED THE INS TO HER STOMACH AND WHEN IT HAD TO BE PUSHED BACK IN. THE PATIENT STATED THAT LONG AFTER THAT, SHE HAD TO HAVE A BLADDER SLING PUT IN FOR HER BLADDER, VAGINA AND RECTUM BECAUSE SHE LOST ALL THE MUSCLE TONE IN HER STOMACH. THE PATIENT STATED THAT IT WAS NOT A WISE DECISION TO GET A STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764124 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