BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM PATIENT PROGRAMMER

    MDR report key: 2163426 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04997
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: (B)(4) - NO ANOMALY FOUND. IPG IS FUNCTIONALLY OKAY. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR THAT MATCHED THE PROGRAMMED SETTINGS AS RECEIVED. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR REFERENCED TO THE #0 ELECTRODE AND ON THE BI-POLAR SETTINGS. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. THE INS BATTERY STATUS ON THE 8840 PROGRAMMER WAS OK. (B)(4) - NO ANOMALY FOUND. EXTENSION IS FUNCTIONALLY OKAY. INS OUTPUT MEASURED THROUGH EXTENSION. CONTINUITY ACCEPTABLE, NO SHORTS. (B)(4) - NO SIGNIFICANT ANOMALIES. LEAD IS FUNCTIONALLY OKAY. VISUAL OBSERVATION. OUTER INSULATION PULLED AWAY FROM CONNECTOR AREA, SEPARATED FROM THE #0 CONNECTOR SLEEVE. SUSPECTED EXPLANT DAMAGE. INS OUTPUT MEASURED AT THE LEAD ELECTRODES. CONTINUITY ACCEPTABLE, NO SHORTS. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: (B)(6); (B)(6) 2011; (B)(6) 2011; (B)(4); MODEL: 3037; (B)(4) 2011; (B)(6).

    Description of Event or Problem · 1

    HAD HER FIRST DEVICE IMPLANTED IN 2005 AND DID WELL WITH THAT DEVICE. SHE HAD REPLACEMENT OF THE IPG DEVICE EXACTLY ONE YEAR AGO IN (B)(6) 2010 AND DID WELL THEN TOO. BUT FOR 4 DAYS PRIOR TO THE SURGICAL PROCEDURE, SHE NOTED SOME INFLAMMATION, SWELLING, TENDERNESS AND SORENESS AROUND HER IPG SITE. THE UROLOGIST HAD TRIED TREATING HER WITH ANTIBIOTICS, BUT IT WAS UNSUCCESSFUL, SO WAS TAKEN TO THE OP FOR I&D OF THE INFECTED ABSCESS AND REMOVAL OF THE INTERSTIM DEVICE. THIS WAS DONE WITH LOCAL WITH HEAVY SEDATION ANESTHESIA. THE SURGEON FOUND A LARGE AMOUNT OF PURULENT MATERIAL WHEN HE MADE THE INCISION. THE DEVICE WAS REMOVED AS WELL AS THE LEAD IN ITS ENTIRETY AND ALL PUS WAS DRAINED. THE WOUND WAS COPIOUSLY IRRIGATED WITH 2 LITERS OF ANTIBIOTIC SALINE CONTAINING ANCEF SOLUTION. THE WOUND WAS CLOSED AND THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME A COUPLE HOURS POST OPERATIVELY. SHE WAS DISCHARGED TO RESUME HER ANTIBIOTIC WHICH HAD PREVIOUSLY BEEN PRESCRIBED (LEVAQUIN). SHE DID RETURN TO THE ED ON (B)(6) 2011 WITH COMPLAINT THAT THE WOUND HAD GOTTEN MORE SWOLLEN, RED, UNCOMFORTABLE AND SHE WAS RUNNING A LOW GRADE FEVER. IN THE ED, SHE RECEIVED A SINGLE DOSE OF IV AMPICILLIN AND IV GENTAMYCIN AND WAS SENT HOME WITH NEW PRESCRIPTION FOR AUGMENTIN IN ADDITION TO THE LEVAQUIN. SHE WAS TO FOLLOW UP WITH HER UROLOGIST THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM PATIENT PROGRAMMER VOIDING DYSFUNCTION DEVICE EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT # NAH041692V| IMPLANTED:| LEAD: MODEL 3093, LOT # J0337557V| EXPLANTED: