BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 18282440 · Received December 7, 2023

    Report

    Report Number
    3004209178-2023-25335
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 1, 2023
    Report Date
    December 7, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000203849
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. 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

    INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING 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 CALLER WAS TRYING TO GET PT'S IMPLANT RECHARGED AND THE RECHARGE WAS NOT WORKING. CALLER PROVIDED EVENT DATE AS "IT WAS LIKE I WANT TO SAY LIKE NOVEMBER 1ST ISH" IS WHEN THEY TRIED TO CHARGE IT AND IT DID NOT WORK AND THEY HAD APPOINTMENT WITH THE HCP THE FOLLOWING WEEK SO THEY WAITED FOR THAT APPOINTMENT. CALLER SAID THEY HAVE CHARGED THE IMPLANT A LOT AND REPORTED THE LAST TIME THEY TRIED TO CHARGE IT THE HANDSET WAS NOT RECOGNIZING THE RECHARGER (REPORTED GETTING RECHARGER NOT FOUND). CALLER STATED WHEN THEY WERE AT PT'S HCP THEY WERE GIVEN A NEW RECHARGER BY THE HCP AND STATED THEY ENTERED THE NEW RECHARGER NUMBER IN MANUALLY TO PAIR RECHARGER BUT REPORTED STILL GETTING RECH ARGER NOT FOUND WITH NEW RECHARGER. CALLER CLARIFIED SAME ISSUE WAS GOING ON WITH BOTH RECHARGERS. CALLER STATED ON CALL THEY ARE CURRENTLY TRYING TO USE NEW RECHARGER AND REPORTED GETTING RECHARGER NOT FOUND ON THE CALL. CALLER ALSO STATED SEEING "ACCOUNT ACTION REQUIRED" WITH A "QVE NUMBER" AND INQUIRED IF THIS COULD HAVE ANYTHING TO DO WITH IT. REVIEWED GENERAL OVERVIEW OF PAIRING RECHARGER WITH HANDSET AND RECHARGER NOT FOUND MESSAGE. CALLER ENSURED RECHARGER WAS POWERED ON AND PRESSED RETRY BUT REPORTED CONTINUED GETTING RECHARGER NOT FOUND MESSAGE. CALLER STATED THEY HAVE ALREADY ENTERED NEW RECHARGER NUMBER IN MANUALLY. CALLER CONFIRMED OLD RECHARGER WAS TURNED OFF (STATED IT WAS LIKELY DEAD) AND WAS AWAY WHEN TROUBLESHOOTING WITH NEW RECHARGER. REVIEWED RECHARGER RESET. CALLER COMPLETED RECHARGER RESET WITH NEW RECHARGER AND TRIED TO CONNECT RECHARGER WITH HANDSET AGAIN BUT REPORTED CONTINUED GETTING RECHARGER NOT FOUND MESSAGE. CALLER ATTEMPTED TO SELECT 'SWITCH RECHARGER' AND SCAN NEW RECHARGER BARCODE, BUT REPORTED SEEING MESSAGE THAT THE SECURITY POLICY PREVENTS THE USE OF THE CAMERA AND WAS UNABLE TO SCAN THE CODE. CALLER ENTERED IN MANUALLY AND ATTEMPTED TO CONNECT RECHARGER WITH HANDSET AGAIN FOLLOWING THIS BUT REPORTED GETTING RECHARGER NOT FOUND AGAIN. CALLER STATED THEY HAVE ENTE RED CODE AT LEAST 4-5 TIMES AND IT HAS NOT WORKED YET. REVIEWED RECHARGER NOT FOUND MESSAGE OVERVIEW. CALLER POWERED OFF NEW RECHARGER AND SET ASIDE AND ATTEMPTED TO USE OLD RECHARGER BUT REPORTED OLD RECHARGER WAS DEAD. CALLER PLACED OLD RECHARGER ON CHARGER. CALLER WILL ATTEMPT TO PAIR OLD RECHARGER WITH HANDSET ONCE OLD RECHARGER IS CHARGED AND WILL PERFORM RECHARGER RESET WITH OLD RECHARGER IF CONTINUES GETTING NOT FOUND. AGENT REVIEWED PT CAN CONTINUE TO CHARGE IMPLANT WITHOUT USE OF RECHARGER APP. CALLER STATED THEY WERE NOT INFORMED OF THIS BY PT'S HCP. CALLER STATED THEY HEAR ASCENDING TONES LIKE RECHARGER IS CONNECTED WITH PT'S IMPLANT WHEN PLACED ON PT'S IMPLANT, BUT RECHARGER IS NOT CONNECTING WITH HANDSET. REVIEWED HOW TO CHECK IMPLANT BATTERY STATUS IN APPLICATION. CALLER CONNECTED WITH PT'S IMPLANT IN APPLICATION AND ONCE CONNECTED, REPORTED GETTING POR DETECTED MESSAGE. AGENT REVIEWED POR MESSAGE MEANING. CALLER DISMISSED POR MESSAGE AND CHECKED IMPLANT BATTERY STATUS. CALLER STATED PT'S IMPLANT BATTERY SHOWED 60%. CALLER STATED THERE IS NO WAY PT'S IMPLANT IS AT 60% AS THEY HAVE BEEN TRYING TO CHARGE AND DIDN'T THINK THEY HAVE CHARGED IN A MONTH AND A HALF. CALLER STATED THEY HAVE HAD RECHARGER ON PT'S IMPLANT WHILE TRYING TO PAIR RECHARGER WITH RECHARGER APP. AGENT REVIEWED IMPLANT WILL STILL CHARGE WHEN NOT CONNECTED WITH APP. PT WILL CONTINUE TO CHARGE IMPLANT. CALLER PROVIDED SUGGESTION THAT RECHARGER APP SHOULD BE AVAILABLE ON PERSONAL PHONE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. CALLER WILL TRY TO RESET OLD RECHARGER ONCE CHARGED AND WILL TRY TO PAIR WITH HANDSET. CALLER WILL CALL BACK IF NOT ABLE TO RESOLVE WITH RESET FOR FURTHER TROUBLESHOOTING. THE FOLLOWING UNRELATED MEDICAL INFORMATION WAS MENTIONED: CALLER STATED PT HAD SURGERY ON THEIR ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366143 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97810 00763000203849

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female