BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3776901 · Received April 28, 2014

    Report

    Report Number
    3007566237-2014-01177
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # V238369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT # V241897, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT, PRODUCT ID 3093-33, LOT# V238369, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V241897, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REVISION AND BATTERY REPLACEMENT SURGERY ON (B)(6) 2014. (SEE MANUFACTURER'S REPORT # 300420 9178-2014-08174). THE FIRST WEEK AFTER SURGERY WAS GOOD AND THE PATIENT HAD NO SYMPTOMS OF OVERACTIVE BLADDER. ON (B)(6) 2014 THE PATIENT WENT FOR A WALK AND HER BACK STARTED TO HURT WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. ON (B)(6) 2014 THE PATIENT HAD A RETURN IN SYMPTOMS WITH LEAKAGE, SUDDEN URGE TO GO TO THE BATHROOM, AND BACK PAIN. THE PATIENT HAD PAIN AT THE IMPLANT SITE. THE PATIENT FELT STIMULATION. THE PATIENT CONFIRMED WITH THE PROGRAMMER THAT THE DEVICE WAS ON. THE PATIENT WAS ON PROGRAM 2 AT 1.4 AMP. WHEN THE PATIENT WAS FIRST IMPLANTED, SHE WAS AT 1.2 AMP AND THEN SHE RAISED IT TO 1.4 AMP WHEN SHE STARTED HAVING PROBLEMS. THE PATIENT LEFT A MESSAGE FOR THE MANUFACTURER'S REPRESENTATIVE ON (B)(6) AND HAD NOT GOTTEN A RETURN CALL. THE PATIENT CALLED HER HCP (HEALTHCARE PROVIDER) AND WAS TOLD TO CALL THE MANUFACTURER. THE PATIENT PLANNED TO WORK WITH HER PROGRAMS AND SEE IF SHE HAS ANY IMPROVEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT SAW HCP (HEALTHCARE PROVIDER) AGAIN THE NEXT WEEK AFTER IMPLANT, ABOUT 3 OR 4 DAYS LATER AND EVERYTHING WAS GOING REALLY NICELY. THE PATIENT WAS NOT HAVING ANY LEAKAGE OR SUDDEN URGES OR ANYTHING AND THE PATIENT FELT PRETTY GOOD. THEN A FEW DAYS LATER ON (B)(6), THE PATIENT WENT FOR A WALK ON THE BEACH AND THE BEACH IS ON A SLANT. THE PATIENT WALKED SO LONG THAT THE PATIENT'S BACK STARTED TO HURT BADLY AND AFTER THAT THE PATIENT STARTED GETTING SUDDEN URGES AND LEAKAGE EVERYDAY. THE PATIENT ASKED COULD THAT BE BECAUSE THE PATIENT HAD INJURED THE LEADS. THE PATIENT NOTED THE HCP WAS ON MATERNITY LEAVE AND THE PATIENT CAN'T REALLY REACH HCP. THE PATIENT NOTED THAT THE HCP DID SAY THAT THE PATIENT COULD CALL HCP OFFICE AND SEE IF SOMEONE ELSE AT THE CLINIC COULD ASSIST THE PATIENT. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255289 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR