BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2982709 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03150
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA01AJ8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THE PATIENT WAS 'NOT GETTING GOOD RELIEF OF SYMPTOMS.' IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT HAD 'LOTS OF PAIN.' IT WAS NOTED THAT SINCE THE PATIENT RECEIVED THE IMPLANTABLE NEUROSTIMULATOR (INS), THE PATIENT HAD NOT RECEIVED HELP WITH HER SYMPTOMS. IT WAS STATED THAT THE PATIENT HAD A SUCCESSFUL TRIAL, BUT NOW THE INS IS NOT HELPING AND CAUSING PAIN IN THE 'BICYCLE SEAT AREA.' IT WAS NOTED THAT THE PATIENT HAD THE STIMULATION TURNED UP TO 2.3 AND IT WAS PAINFUL. IT WAS STATED THAT THE PAIN STARTED 2 MONTHS PRIOR TO THIS REPORT. IT WAS STATED THAT THE PATIENT TURNED DOWN HER STIMULATION. IT WAS NOTED THAT WHEN THE DEVICE WAS PUT IN, 'THE POCKET WAS TOO BIG AND THE INS WAS FLIPPING AND POKING OUT OF THE SKIN AND THE LEAD WAS PUT IN THE WRONG PLACE.' IT WAS NOTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2012 AND THAT THE PHYSICIAN 'PUT THE INS IN THE RIGHT SIDE AND PUT THE LEAD IN THE CORRECT PLACE.' IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PATIENT¿S SYMPTOMS INCLUDED USING PADS EVERY DAY AS WELL AS NOT BEING ABLE TO MAKE IT TO THE BATHROOM. THE PATIENT ALSO HAD TO USE ¿DEPENDS¿ AT NIGHT BECAUSE SHE WOKE UP ¿SOAKED¿. FOLLOW-UP WITH THE PATIENT¿S HEALTHCARE PROVIDER (HCP) INDICATED THAT AN X-RAY WAS DONE IN 2012 WHICH SHOWED THAT THE PATIENT¿S LEADS HAD MIGRATED UP HER BACK. ADDITIONALLY, THE INS WAS ¿BULGING OUT AND TURNED UP WHEN SHE SAT DOWN¿. THE REPORTER INDICATED THAT WHEN THE PATIENT WAS ON HER WAY HOME AFTER THE INITIAL IMPLANT, THE DRIVER OF THE CAR ¿SLAMMED ON THE BREAKS¿ TO KEEP FROM HITTING A TRUCK WHICH ¿THREW THE PATIENT IN THE FLOOR BOARD¿. IT WAS NOTED THAT ¿THAT WAS PROBABLY WHEN IT HAPPENED¿. AS OF (B)(6) 2012 THE PATIENT WAS WAITING TO BE SCHEDULED FOR A SURGICAL REVISION. THIS REVISION WAS PREVIOUSLY REPORTED TO HAVE OCCURRED IN DECEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88541 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention