BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4017851 · Received August 18, 2014

    Report

    Report Number
    6000032-2014-00165
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    August 12, 2002
    Report Date
    August 21, 2002
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDWATCH FILED IN ERROR AS EVENT PREVIOUSLY REPORTED ON (B)(6) 2002. INITIAL MEDWATCH OF THIS SUPPLEMENTAL, CORRECTIVE MDR IS BEING REDACTED AS IT IS A DUPLICATE MEDWATCH - SEE MANUFACTURING REPORT # 6000033-2002-00690.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 4351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 4351, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SURGICAL REPLACEMENT OF ORIGINAL DEVICE, LAPAROSCOPIC JEJUNOSTOMY TUBE (J-TUBE) PLACEMENT, SUSPECTED NEUROSTIMULATOR MALFUNCTION, HEMATOMA OR SEROMA AT POCKET SITE, LEAD PERFORATION AND EROSION OF THE LEADS FROM THE GASTRIC STIMULATOR TRANSMURALLY THROUGH THE GASTRIC WALL. ON (B)(6) 2002, THE PATIENT REPORTEDLY WOKE UP WITH THE NEUROSTIMULATOR ¿STICKING STRAIGHT OUT FROM HER BODY AND JUMPING AROUND.¿ IT WAS NOTED THAT IT WAS ¿VERY PAINFUL¿ AND THE PATIENT BECAME ¿EVEN MORE NAUSEATED.¿ THE DEVICE WAS CHECKED DURING HER HEALTHCARE PROFESSIONAL APPOINTMENT WHERE THE IMPEDANCE WAS CHECKED. IT WAS DECIDED ON (B)(6) 2002 TO HAVE SURGERY ON (B)(6) 2002 FOR J-TUBE PLACEMENT AND ¿POSSIBLE REPLACEMENT¿ OF GASTRIC STIMULATOR. IT WAS NOTED THAT THE PATIENT WAS MALNOURISHED AND AN IMPEDANCE CHECK HAD IMPEDANCES THAT WERE ¿EXTREMELY HIGH, SUGGESTIVE OF SOME DISRUPTION OF THE LEADS.¿ LEAD PERFORATION WAS DISCOVERED WHILE PERFORMING ESOPHAGOGASTRODUODENOSCOPY WHERE THE EXAMINATION REVEALED PERFORATION OF THE GASTRIC MUCOSA BY THE LEAD. THERE WAS ALSO INFECTED FLUID COLLECTION SURROUNDING THE NEUROSTIMULATOR WHICH WAS DISCOVERED WHEN CONNECTING THE NEW LEADS. UPON OPENING THE CAVITY, THE NEUROSTIMULATOR WAS NOTED TO HAVE BEEN ¿FREE FLOATING IN TURBID BROWN FLUID.¿ IT WAS NOTED THAT THE LEAD CONNECTED TO THE STIMULATOR WAS TANGLED AND KNOTTED; IT WAS SUGGESTED BY THE HEALTHCARE PROVIDER THAT THE FREE FLOATING NEUROSTIMULATOR WAS ¿ABLE TO SPIN WITHIN THE SUBCUTANEOUS CAVITY, ALLOWING THE LEADS TO BECOME ENTANGLED.¿ IT WAS NOTED THAT THERE WAS A SURGICAL INTERVENTION AS THE LEADS AND NEUROSTIMULATOR WERE REPLACED ON (B)(6) 2002. IT WAS NOTED THAT ONE LEAD WAS REPLACED DUE TO PERFORATION AND THE OTHER DUE TO ¿KNOTTING.¿ THE ¿PSEUDOCAPSULE WITHIN THE CAVITY¿ WAS REMOVED WITH ELECTROCAUTERY. IT WAS NOTED THAT A FRESH SITE WAS USED TO PLACE THE NEW NEUROSTIMULATOR. THE PATIENT REPORTEDLY ¿TOLERATED THIS PROCEDURE VERY WELL AND RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION;¿ OUTCOME OF EVENT WAS ¿CLOSED¿ AS OF (B)(6) 2002. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495972 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R