BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12070502 · Received June 25, 2021

    Report

    Report Number
    3004209178-2021-10005
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 22, 2021
    Report Date
    August 7, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V955729, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IN RESPONSE TO THE INQUIRY REGARDING THE PATIENT STATING, THEY HAD A RECHARGER ADAPTOR, BUT DID NOT HAVE A RECHARGER CABLE. AND THE BOX WAS OPEN WHEN THEY GOT IT. AND IF THERE HAD BEEN A DEVICE CONCERN OR AN OUT-OF-BOX ISSUE, ETC.. THE REP REPLIED, THAT THE PATIENT HAD RECEIVED A NEW SMART PROGRAMMER. AND THE BOX WAS OPEN, SO IT COULD BE PAIRED WITH THEIR NEW BATTERY. THE REP STATED, THAT ALL COMPONENTS WERE THERE. IN RESPONSE TO THE INQUIRY, FOR IF THE CAUSE OF THE INTERMITTENT STIMULATION (THE PATIENT COULD FEEL ¿THE PULSE¿) HAD BEEN DETERMINED, AND WHAT MOST LIKELY, CAUSED OR CONTRIBUTED TO THE ISSUE. THE REP REPLIED, THAT THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH THE HEALTH CARE PROFESSIONAL (HCP). AND THE PATIENT WAS FEELING STIMULATION AND GETTING RELIEF ACCORDING TO THE HCP. IN RESPONSE TO WHAT STEPS WERE OR WOULD BE TAKEN TO RESOLVE THE ISSUE. AND IF THE ISSUE HAD BEEN RESOLVED, THE REP REPLIED AGAIN, THAT THE PATIENT SAW THE HCP AND WAS SEEING RELIEF. IN RESPONSE TO THE INQUIRY FOR WHAT MOST LIKELY, CAUSED OR CONTRIBUTED TO THE LACK OF STIMULATION SENSATION. AND ONLY TWO OF THE SEVEN PROGRAMS WORKING. THE REPLIED ¿UNKNOWN¿, BUT REPLIED ¿YES¿. THE ISSUE HAD BEEN RESOLVED. IN RESPONSE TO THE INQUIRY FOR CLARIFICATION OF THE STATEMENT ¿THE PATIENT WAS CONCERNED, BECAUSE THE MANUFACTURER REPRESENTATIVE (REP) WAS SUPPOSED TO CHECK THE LEAD IN SURGERY. AND THEY WERE CONCERNED THAT THEY MIGHT NOT HAVE, BECAUSE ONLY TWO OF THE PATIENT¿S PROGRAMS WORKED OUT OF SEVEN. AND WHY WOULD ONLY 2 OF THEM WORK, IF THEY DID¿. AND IF THERE WAS A DEVICE/LEAD CONCERN, THERAPY ISSUE/ PROCEDURE/USE ISSUE, ETC., THE REP REPLIED, THAT THE IMPEDANCES WERE CHECKED BY THE REP AND THE HCP, DURING THE PROCEDURE. AND THE LEAD SHOWED NO IMPEDANCES. AND THAT ¿NO¿. THE CAUSE OF THE LEAD ISSUE WAS NOT DETERMINED, BUT ¿YES¿, THE ISSUE HAD BEEN RESOLVED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V955729, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. ]OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 29-FEB-2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD THE STIMULATOR REPLACED ON THE (B)(6). THIS WAS THE THIRD ONE. THEIR OLD BATTERY WENT OUT (DUE TO NORMAL BATTERY DEPLETION). PATIENT ASKED IF THEY CHECKED THE LEADS AND THEY SAID THEY DID. THE PATIENT HAD NEVER SEEN NOR TALKED TO THE MANUFACTURER REPRESENTATIVE AND HAD BEEN TRYING TO GET AHOLD OF THEM. THE PATIENT WAS NOT TRAINED ON THEIR IMPLANT. THEY CALLED THEIR DOCTOR AND THEIR DOCTOR TEXTED THE REPRESENTATIVE, AND THE PATIENT STILL HAD NOT HEARD ANYTHING NOR SEEN THEM. THEY HAD A RECHARGER ADAPTOR, BUT DID NOT HAVE A RECHARGER CABLE. THE BOX WAS OPEN WHEN THEY GOT IT. THE REPRESENTATIVE LEFT A NOTE WITH THE BOX THAT THE PATIENT RECEIVED WHEN THEY WOKE UP. IT READ, "DEVICE IS ON. GOES HOME WITH PATIENT. PLEASE CALL [MANUFACTURER REPRESENTATIVE] WITH TURNING UP DEVICE." THE PATIENT'S CURRENT SETTING WAS PROGRAM 7 AT 1.6 VOLTS, AND STIMULATION WAS ON. THEY COULD FEEL THE PULSE. THEY NOTED THEY HAD THE DEVICE FOR NEUROGENIC BLADDER. WHEN ASKED IF THE THERAPY WAS WORKING, THEY SAID IT WAS SOMETHING THAT HELPED GRADUALLY OVER TIME. THEY HAD BEEN GOING THROUGH ALL OF THE PROGRAMS THAT MORNING AND ONLY 2 OF THE 7 WORKED. PROGRAMS 3 AND 7 WORKED. THEY HAD THE STIMULATION UP TO 4.0 VOLTS AND DID NOT FEEL ANYTHING AT ALL. THE LEVEL WHEN WORKING WAS 1.5 VOLTS AND 2.0 VOLTS, AND THEY USUALLY COULD NOT GET PAST 2.5 VOLTS AND "HURTS SO BAD." THEY WERE TOLD WHEN THEY WENT IN THEY WERE GOING TO TEST IT, BUT THE PATIENT WAS NOT SURE THEY DID. THEY WERE CONCERNED BECAUSE THE MANUFACTURER REPRESENTATIVE WAS SUPPOSED TO CHECK THE LEAD IN SURGERY AND THEY WERE CONCERNED THEY MIGHT NOT HAVE BECAUSE ONLY TWO OF THEIR PROGRAMS WORKED OUT OF SEVEN. THEY SAID, "WHY WOULD ONLY TWO OF THE PROGRAMS WORK IF THEY DID?" ADDITIONAL INFORMATION WAS RECEIVED THE FOLLOWING DAY. THE PATIENT NOTED THEY WERE TOLD THEY WERE GOING TO CHECK THE LEADS WHEN THEY WENT IN TO CHANGE OUT THE STIMULATOR. THEY WERE TOLD THEY DID, BUT ONLY TWO OF THE SEVEN PROGRAMS WERE WORKING. THEY WANTED TO KNOW IF THEY CHECKED THE LEADS, WHY ONLY TWO PROGRAMS WOULD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961659 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR "SEE H10"| "SEE H10"