BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3735322 · Received April 9, 2014

    Report

    Report Number
    3004209178-2014-05837
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    September 29, 2018
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO (B)(4) HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSIONS CODES NO LONGER APPLY TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN TO LOSE THERAPEUTIC EFFECT AROUND (B)(6) 2013. IT WAS STATED THAT AS TIME WENT ON, THE THERAPEUTIC BENEFIT HAD GOTTEN WORSE. IT WAS STATE THAT THE PATIENT WAS LAST ADJUSTED IN (B)(6) OF 2013. THE PATIENT ONLY FELT STIMULATION 3 TIMES A DAY, IF THAT. THE THERAPY ADJUSTMENTS DID NOT SEEM TO BE HELPING THE PATIENT. IT ALSO STATED THAT DURING AN ADJUSTMENT SHORTLY AFTER IMPLANT, STIMULATION WAS INCREASED ¿REALLY HIGH¿ AND IT FELT LIKE SOMEONE PUT AN ¿ELECTRICAL PROD ON THE END OF HIS PENIS.¿ THE OVERSTIMULATION WAS PAINFUL AND THAT PATIENT HAD NOT EXPERIENCED THAT AGAIN. IT WAS LATER REPORTED THAT THE PATIENT WAS TO HAVE A HEAD MRI. THE PATIENT THOUGHT THE MRI MIGHT HAVE SOMETHING TO DO WITH HIS THERAPY CHANGES THAT STARTED AROUND (B)(6) 2013. IT WAS ALSO STATED THAT WHEN THE PATIENT MADE LOVE TO HIS WIFE, HE FELT A ¿ZING¿ ON HIS LEFT SIDE WHEN HE CLIMAXED. THE SENSATION MADE THE PATIENT ¿NOT WANT TO MESS AROUND.¿ THE PATIENT HAD NOT CONTACTED HIS DOCTOR ABOUT HIS RETURN OF SYMPTOMS. IT WAS LATER REPORTED THE PATIENT WAS ON PROGRAM 4 AT 1.1 VOLTS WITH THE LIGHTNING BOLT. IT WAS NOTED THE PATIENT¿S OTHER PROGRAMS WERE PROGRAM 3 AT 1.8 VOLTS, PROGRAM 1 AT 1.6 VOLTS AND PROGRAM 2 AT 1.6 VOLTS. THE PATIENT STATED THAT ONE TIME THEY ¿CHANGE IT UP¿ AND THOUGHT ¿HE HAD STUCK HIS PENIS RIGHT INTO A LIGHT SOCKET¿ BUT THE PATIENT NOTED IT WAS QUITE A WHILE AGO. THE PATIENT INCREASED UP TO 1.15 VOLTS ON PROGRAM 4. IT WAS NOTED THE PATIENT WENT THROUGH PROGRAMMING ADJUSTMENT WHEN THEY FELT IT AND ¿THEY BACK OFF.¿ REPORTEDLY, THE PATIENT COULD GO ALL NIGHT AND NOT GO TO THE BATHROOM BUT THEY HAD TO GO EVERY TWO HOURS ONCE THEY GOT UP. IT WAS STATED THE PATIENT HAD BEEN CHECKING CONSISTENTLY FOR A WEEK AND HAD THEIR DEVICE CHECKED OR REPROGRAMMED BUT SHORTLY AFTER THAT ¿IT WENT INTO MODE EVERY 2 HOURS.¿ IT WAS NOTED THAT IN (B)(6) 2013, THE PATIENT HAD A MAJOR SURGERY AND HAD 21 INCHES TAKEN OUT OF THEIR COLON. REPORTEDLY, THE PATIENT FELT THE MACHINE WARM NOT HOT WHEN THEY LAY DOWN. THE PATIENT THOUGHT IT HAD TO DO WITH THEIR POSITION BECAUSE WHEN THEY SIT OR STOOD IT WAS EVERY TWO HOURS BUT WHEN THEY LAY DOWN THEY COULD GO ALL NIGHT. THE PATIENT STATED THEY CHANGED THE SETTING BECAUSE THEY WEREN¿T ABLE TO FEEL IT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT UP TO A POINT THE PATIENT'S THERAPY WAS WORKING REALLY WELL. IT WAS NOTED THEY WERE ABLE TO GO ALL NIGHT BUT THEN THINGS STARTED TO CHANGE DURING THE DAY AND THEY WOULD GO LESS THAN EVERY 3 HOURS AND JUST RECENTLY THINGS STARTED TO CHANGE AGAIN. IT WAS STATED THAT TWO NIGHTS PRIOR TO REPORT THE PATIENT WENT 2 TIMES AFTER 12 AM AND THE NIGHT PRIOR TO REPORT THEY WENT 3 TIMES AFTER 12 AM. REPORTEDLY, THE PATIENT HAD NOT FELT STIMULATION FOR A WHILE AND THEY WERE NOT ACCUSTOMED TO THE PROGRAMMER BECAUSE THEY NEVER REALLY HAD TO USE IT. IT WAS STATED THIS ISSUE STARTED GRADUALLY AROUND LAST SPRING. IT WAS NOTED THE PATIENT WAS ON PROGRAM 1 AT 1.45 VOLTS AND THEIR STIMULATION WAS ON. THE PATIENT INCREASED TO 1.55 VOLTS AND THEY STATED THEY WERE FEELING STIMULATION THEN AT THE END OF THEIR PENIS. THE PATIENT STATED WHEN THEY FIRST PUT IT IN THAT WAS NOT WHERE THEY WERE FEELING IT BEFORE. IT WAS NOTED THAT WHEN IT WAS WORKING THEY WOULD FEEL JUST LITTLE TINY THINGS THAT DIDN'T HURT BUT LET THEM KNOW IT WAS ON AND WORKING. IT WAS REPORTED THE PATIENT WAS WITH THEIR MANUFACTURER REPRESENTATIVE ABOUT 1.5 YEARS PRIOR TO REPORT AND THEY WERE MAKING AN ADJUSTMENT AND THE PATIENT FELT SOMETHING THAT WAS LIKE A BOLT OF LIGHTNING. IT WAS STATED THE PATIENT WASN'T SURE IF THEY WERE CHANGING PROGRAMS OR JUST INCREASING IT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PATIENT HAD BEEN ON PROGRAM 1 FOR A WHILE AND HAD BEEN WORKING WELL BUT RECENTLY PATIENT HAD RETURN OF SYMPTOMS. THE PATIENT WAS GOING TO THE GOING TO BATHROOM EVERY HOUR OR LESS FOR THE PAST TWO WEEKS. IT WAS ALSO INDICATED THAT PATIENT HAD AN X-RAY DONE AND COLONOSCOPY TWO WEEKS AGO AND SAW A CHIROPRACTOR ON THE DAY OF THIS CALL AND THEY USED ELECTRICAL STIMULATION CLOSE TO IMPLANT. THE PATIENT STATED CHIROPRACTOR ASKED IF PATIENT COULD HAVE ELECTRICAL STIMULATION AND PATIENT DID NOT KNOW. THE PATIENT SETTING WAS ON PROGRAM 3 AT 1.95V. THE PATIENT WAS NOT SEEING CODE ON PATIENT PROGRAMMER (PP) SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213573 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR