BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2083036 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03250
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2010
    Report Date
    October 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED INTERNAL TRAUMA, INCLUDING BOWEL PERFORATION, AS THE RESULT OF FRACTURED LEADS THE D EGREE OF INFECTION DUE TO THE DUODENAL PERFORATION RESULTED IN THE PROLONGED HOSPITALIZATION."

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT POSSIBLY DUE TO BATTERY END OF LIFE. ADD'L INFO RECEIVED ON (B)(6) 2011 REPORTS THE PT WAS EXPERIENCING NAUSEA AND VOMITING. HER PHYSICIAN DID AN X-RAY AND DISCOVERED THAT THE PT HAD 1.5 INCHES OF OLD LEAD (DISTAL) LEFT IN HER STOMACH AREA THAT HAD MIGRATED AND WAS CLOSE TO THE DUODENUM. THE PT WAS NOT AWARE ANY PARTS OF THE OLD SYSTEM WERE LEFT IMPLANTED WHEN THE NEW SYSTEM WAS PLACED ON (B)(6) 2010. WHEN THE DEVICE WAS INTERROGATED PRIOR TO REPLACEMENT LAST YEAR THE PHYSICIAN AND MFR'S REP WERE UNABLE TO GET ANY IMPEDANCE READINGS. X-RAYS LOOKED AS IF THE LEADS WERE CUT. DURING THE OPERATION, THE PHYSICIAN FOUND THE DEVICE HAD BEEN FLIPPED MULTIPLE TIMES IN THE POCKET, LEADS WERE TWISTED AND BROKEN, POSSIBLY DUE TO "TWIDDLER'S SYNDROME". THE PT WAS INVESTIGATING HER OPTIONS AND TRYING TO DECIDE WHETHER TO REMOVE THE MIGRATED LEAD. SHE WAS LOOKING FOR A NEW PHYSICIAN TO CONSULT. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA INTESTINAL STIMULATOR LNQ MDT PUERTO RICO OPERATIONS CO 3116 H0025211

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Hospitalization| R EXPLANTED:| LEAD: MODEL 4351, LOT# NHT002258N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT002856N| EXPLANTED:| IMPLANTED: