BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3243333 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12189
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA091QC, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. IT WAS NOTED THAT THERE WAS A SHOCKING SENSATION AT THE POCKET. IT WAS FURTHER NOTED THAT WHEN IT WAS PUSHED THE PATIENT ¿FELT THE CHANGE.¿ THE PATIENT NOTICED THE POCKET STIMULATION A ¿FEW DAYS¿ PRIOR TO THE DATE OF THIS REPORT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. IT WAS NOTED THE PATIENT WAS AN AMPUTEE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE DEVICE WAS TURNED OFF, THE PATIENT STILL EXPERIENCED ¿THE SAME THING.¿ IT WAS NOTED THAT THE INCISION WAS NOT INFECTED. THE HEALTH CARE PROFESSIONAL (HCP) BELIEVED THE PATIENT HAD SKIN PARASTHESIA. A TOPICAL CREAM WAS PRESCRIBED. IT WAS DETERMINED THAT IT WAS NOT THE DEVICE AND ¿NO MALFUNCTION CAUSE SKIN PARASTHESIA. THE PATIENT WAS ¿OK¿ WITH THE BATTERY ON. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH THE HCP AND WANTED THE IMPLANTABLE NEUROSTIMULATOR (INS) MOVED AS THE PATIENT THOUGHT IT WAS PINCHING A NERVE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD A DEVICE IMPLANTED A COUPLE MONTHS PRIOR TO REPORT AND THEY HAD TRIED EIGHT DIFFERENT PROGRAMS SINCE IMPLANT. THE PATIENT STATED THEY SEEMED TO HAVE RUN OUT OF PROGRAMS THAT "WORK OR DO ANYTHING." REPORTEDLY, THE PATIENT WAS TOLD AT THE HEALTHCARE PROVIDER'S OFFICE THAT THERE WAS NO MORE THEY COULD DO FOR THE PATIENT. IT WAS NOTED THAT AFTER THEIR DEVICE WAS IMPLANTED THEY HAD TO GO BACK IN FOR SURGERY A COUPLE WEEKS AFTER IMPLANT TO MOVE THE INS AND THEN GO BACK IN AGAIN ABOUT 6-8 WEEKS AFTER THAT TO MOVE THE LEAD WIRE. THE PATIENT HAD SHOCKS AND NUMBNESS ON THE RIGHT SIDE ALMOST SINCE IMPLANT AND SOMETIMES THEY WERE WORSE THAN OTHERS. THE PATIENT REPORTED THEY HAD THE UNIT SHUT OFF AND WERE STILL GETTING SHOCKS. THE PATIENT SAID THAT SINCE THEIR FIRST UNIT WAS IN THAT TWO OF THE PROGRAMS DID NOT WORK AND ONE WAS IN THE FIRST 4 PROGRAMS AND ONE WAS IN THE SECOND 4 PROGRAMS. IT WAS NOTED THAT THEY SHOWED NO FUNCTION AT ALL AND THE PATIENT STATED "THE PROGRAM IS DEAD." NONE OF THE PATIENT'S EIGHT PROGRAMS WORKED VERY WELL THERAPEUTICALLY AND NOTHING REALLY WORKED VERY WELL FOR MORE THAN A DAY OR TWO AND THE PATIENT WAS TOLD THAT MAY HAVE JUST BEEN IN ANTICIPATION OF IT WORKING OR HOPING IT WOULD WORK. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343269 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention