BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 11205255 · Received January 20, 2021

    Report

    Report Number
    3004209178-2021-01072
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    November 16, 2020
    Report Date
    July 15, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000203849
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE WIRELESS RECHARGER WAS A CONCOMITANT PRODUCT, BUT SHOULD NOT HAVE BEEN ADDED IN THE PREVIOUS REPORT. H6: NOTE THAT THE FOLLOWING CODES SHOULD NOT HAVE BEEN INCLUDED IN THE PREVIOUS REPORT A1005, E170501, F12. 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE INS, PLI# 20 PRODUCT ID# 97810, S/N (B)(6) SHOWED THAT THE RETURNED DEVICE PASSED ALL TESTING IN THE LABORATORY AND NO ANOMALIES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT HAD BEEN DETERMINED THAT THE PATIENT'S DEVICE HAD SOMEHOW MIGRATED TOO DEEP DURING THE RECENT WEEKS (PRIOR TO EXPLANT) AND COULD NO LONGER BE RECHARGED. THE HCP HAD EXPRESSED THAT THIS WAS UNACCEPTABLE. THE HCP HAD BEEN VIGILANT ABOUT IMPLANTING AT THE RECOMMENDED 1/2 INCH DEPTH DIRECTED BY THE MANUFACTURER. THE HCP ALSO EXPRESSED CONCERN THAT THE PATIENT CHOSE A 15 YEAR DEVICE SO NOT TO HAVE TO RETURN TO SURGERY, BUT HERE THEY WERE HAVING TO RETURN TO SURGERY JUST A FEW MONTHS LATER FOR A 'POCKET REVISION'. THE DEVICE WAS REPLACED WITH A NON-RECHARGEABLE SYSTEM. THE REP REPORTED THAT REPLACING THE DEVICE HAD RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: WR9220, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER, PRODUCT ID: CD9000, SERIAL# (B)(4), PRODUCT TYPE: ACCESSORY. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: WR9220, SERIAL/LOT #: (B)(4). 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 THERAPY. IT WAS REPORTED THAT FOR THE LAST COUPLE OF WEEKS THE PATIENT HAD BEEN HAVING A HARD TIME CHARGING THEIR IMPLANT. THEY HAVE BEEN RECEIVING ERROR CODE 1707 AS WELL AS COUPLING ISSUES. IF THE RECHARGER CONNECTED TO THE DEVICE TO START A CHARGING SESSION, THE CONNECTION WOULD DROP SHORTLY AFTER AND THE HANDSET WOULD GO BACK TO SEARCHING FOR DEVICE. THEIR IMPLANT WAS CURRENTLY DEAD AND THEY COULDN'T CHARGE IT. ON THE CALL, PATIENT SERVICES HAD THE CALLER LINE UP THE BOTTOM EDGE OF THE RECHARGER WITH THE BOTTOM EDGE OF THE IMPLANT (CALLER WAS USING THE BELT WITH THE RECHARGER ON THE SKIN) AND THE CALLER RECEIVED ANOTHER 1707 ERROR CODE. THE CALLER CONFIRMED THAT THEY COULD FEEL THE IMPLANT UNDER THEIR SKIN. THE CALLER THEN RESTARTED THE RECHARGER AND AFTER THIS WAS COMPLETED THE CALLER RECEIVED A (HOLDING THE RECHARGER IN PLACE) BURNING SENSATION FROM THE "GOLD PRONGS"- PATIENT SERVICES RECOMMENDED A THIN LAYER OF CLOTHING AND THE CALLER CONFIRMED THEY NO LONGER FEEL THE SENSATION- THEN THE CALLER RECEIVED A NOT FOUND: RECHARGER MESSAGE. PATIENT SERVICES THEN HAD THE CALLER RESTART ALL EXTERNAL EQUIPMENT (HANDSET AND RECHARGER) AND AFTER THIS WAS DONE THE CALLER PLACED THE CENTER OF THE RECHARGER IN LINE WITH THE CENTER OF THE IMPLANT (USED A THIN LAYER OF CLOTHING, HOLDING THE RECHARGER) AND THE CALLER STARTED A CHARGING SESSION FOR A SHORT SECOND THEN THE CONNECTION DROPPED TO SEARCHING FOR DEVICE. THE HANDSET THEN SHOWED CONNECTING TO RECHARGER BUT THE RECHARGER WAS MAKING DESCENDING TONES AND HAD A RED FLASHING LIGHT. THE CALLER THEN POWERED OFF AND ON THE RECHARGER AND WAS ABLE TO START A CHARGING SESSION FOR A QUICK SECOND THEN RECEIVED THE SAME NOT FOUND MESSAGE. PATIENT SERVICES HAD THE CALLER RESTART THE RECHARGER AGAIN (TIMED ON THE CALL- 40 SECONDS UNTIL LIGHTS FLASHED) AND TURN THE RECHARGER VOLUME OFF. AFTER THIS WAS DONE, THE CALLER STARTED A CHARGING SESSION FOR ANOTHER QUICK SECOND THEN DROPPED THE CONNECTION AGAIN (HANDSET SAID SEARCHING FOR DEVICE). THE CALLER THEN PUT THE RECHARGER IN THE BELT AND THE HANDSET NEVER PROGRESSED PAST THE SEARCHING FOR DEVICE SCREEN. THE CALLER THEN ENDED WITH A 4100 ERROR CODE. PATIENT SERVICES REVIEWED THE POSSIBILITY OF REPLACING THE EQUIPMENT, BUT IF THE ISSUE PERSISTS, IN PERSON TROUBLESHOOTING MAY BE NEEDED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT FOR REPLACEMENT RECHARGING EQUIPMENT. ADDITIONAL INFORMATION REPORTED ON 2020-DEC -01 STATED THAT THEY WERE SENT A REPLACEMENT RECHARGING EQUIPMENT AND THE REP REPORTED THEY WERE ABLE TO SUCCESSFULLY CHARGE THEIR IMPLANT. THE CAUSE OF THE RECHARGING DIFFICULTIES WAS NOT KNOWN AND THERE WERE NO KNOWN CONTRIBUTING FACTORS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2020-DEC-04. THEY REPORTED THAT THEY WERE STILL HAVING THE SAME ISSUE WITH THE REPLACEMENT EQUIPMENT. THE CALLER STATED THAT THE DEVICE WOULD FIND THE CONNECTION MOMENTARILY AND THEN LOSE IT AND GO BACK TO SEARCHING. PATIENT SERVICES DID ALL RECOMMENDED TROUBLESHOOTING FOR 20 MINUTES WITH NO SUCCESS. PATIENT SERVICES REDIRECTED THE PATIENT TO THEIR HCP. ADDITIONAL INFORMATION RECEIVED ON 2020-DEC -28 FROM REP STATED IT IS REPORTED THAT PATIENT HAS NOT CHARGED TO 100%. PER DOCTOR ¿THE RECHARGING EQUIPMENT IS POOR QUALITY AS IT CAN NOT MAKE CONNECTION WITH DEVICE". HOWEVER, THE COMMUNICATOR HAD NO ISSUE CONNECTING WHICH MAKES NO SENSE, WHY ONE COULD CONNECT AND THE OTHER COULD NOT, ¿TOO DEEP¿ SOUNDS LIKE AN EXCUSE FOR A POORLY DESIGNED RECHARGING UNIT¿ THE REPRESENTATIVE STATED THAT THE LIKELY CAUSE WAS DUE TO POOR QUALITY AND DESIGN OF RECHARGING UNIT¿ THE DOCTOR HAS SCHEDULED PATIENT FOR REMOVAL OF MICRO SYSTEM AND WILL BE REPLACING WITH NON-RECHARGE SYSTEM IN JANUARY. NO DATE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 2021-01-08 FROM THE REP STATING THE PATIENT AND SURGEON WANT TO REPLACE THE PATIENT'S DEVICE WITH AN INTERSTIM II ASAP. EMPLOYEE SAID THE PHYSICIAN WOULD LIKE REPRESENTATIVE TO PROVIDE THE NEEDED REPLACEMENT COMPONENTS AT NO CHARGE UP FRONT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99685 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97810 00763000203849

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention "SEE H10...."