BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 14975759 · Received July 11, 2022

    Report

    Report Number
    3004209178-2022-08698
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    June 13, 2022
    Report Date
    July 11, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-33 LOT# V022886 SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-33, SERIAL/LOT #: V022886, UBD: 22-FEB-2011, UDI#: (B)(4). 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

    CONTINUATION OF D10: PRODUCT ID: 3889-33, LOT# V022886, IMPLANTED: (B)(6) 2007, 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) ATTENDED PROCEDURE THE MORNING OF THE REPORT THAT WAS INTENDED TO BE JUST AN INS REPLACEMENT TO 97800. UPON CONNECTING 97800 TO PATIENT'S EXISTING LEAD, IMPEDANCE RESULTS SHOWED GREATER THAN 4K OHMS ON ALL CONTACTS AFTER SEVERAL IMPEDANCE CHECKS. REP STATED THEY TURNED EVERYTHING OFF IN OR BUT IMPEDANCES REMAINS. CALLER STATED THAT HCP THOUGHT LEAD WAS GOOD PRIOR TO PROCEDURE. CALLER SET-UP PROGRAMMING TO ATTEMPT TO OBTAIN MOTOR RESPONSE BUT WAS HITTING "MAX SETTINGS, CANNOT INCREASE" MESSAGE AROUND 1.3 MA ON MULTIPLE PROGRAMS. THEY TRIED A COUPLE PROGRAMS WHILE IMPEDANCES WERE HIGH HOWEVER THEY  COULDN'T GO HIGHER THAN BETWEEN .8MA-1.5MA.  AT THIS TIME, IT WAS DECIDED TO REPLACE THE LEAD. THE ORIGINAL 97800 WAS CONNECTED TO THE NEW LEAD AND CALLER ATTEMPTED TO USE THE SAME HANDSET AND COMMUNICATOR (THAT WAS ALSO USED FOR TESTING DURING LEAD PLACEMENT) TO CONNECT TO INS BUT IT WASN'T FINDING THE INS. CALLER USED A NEW SET OF HANDSET/COMMUNICATOR AND THAT LOCATED THE INS SERIAL NUMBER BUT WOULDN'T CONNECT TO THE INS FOR THE PROGRAMMER SESSION. CALLER STATED PATIENT WAS STRUGGLING ANESTHESIA-WISE SO THEY WERE NOW IN POST-OP AND HANDSET WAS STILL NOT CONNECTING TO INS. CALLER MENTIONED ONE HANDSET WAS P VERSION AND ONE WAS Q VERSION. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED CALLER DROPPED OFF THE CALL. MORE INFORMATION WAS RECEIVED, THE REP CALLED BACK. THEY STATED THAT HEY TRIED A COUPLE PROGRAMS WHILE IMPEDANCES WERE HIGH AND THEY COULDN'T GO HIGHER THAN BETWEEN .8MA-1.5MA. THE CALLER DECIDED TO GO TO RETRIEVE ANOTHER INS/LEAD TO IMPLANT. THE CALLER STATES THEY TESTED THE NEW LEAD WITH THE EXTERNAL STIMULATOR AND THE IMPEDANCES LOOKED GOOD. CALLER STATES THEY HOOKED THE LEAD/INS TOGETHER BUT AT THAT POINT THEY WERE UNABLE TO FIND THE DEVICE. THE CALLER THOUGHT IT MAY HAVE BEEN BECAUSE HE WAS USING AN OLD 'P' HANDSET THAT HE UPGRADED TO A 'Q' BUT HE HAS NOW TRIED TWO HANDSETS AND TWO COMMUNICATORS AND CANNOT COMMUNICATE. THE CALLER STATES THE INS IS SUPERFICIAL. AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THE REP/DOC ACCIDENTALLY RE-IMPLANTED THE INS THAT WAS INTENDED TO BE REPLACED TODAY. THE REP HAD GRABBED AN INTERSTIM X TO IMPLANT BUT AMONGST THIS PREVIOUS ACTIVITY THEY ENDED UP PLACING THE OLD INTERSTIM II. THE CALLER WILL WORK WITH DOC TO DETERMINE NEXT STEPS. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE ACCIDENTAL RE-IMPLANTATION WAS THAT THE SCRUB TECH DIDN'T PROPERLY DISPOSE OF THE BATTERY; IT WAS NOT REMOVED FROM THE STERILE FIELD RIGHT AWAY. THE PATIENT WAS BROUGHT BACK TO THE SURGICAL SUITE AND LOCAL WAS USED TO REPLACE THE BATTERY. THE REP STATED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THIS ISSUE, AND THE ISSUE WAS RESOLVED. WHEN ASKED ABOUT THE CAUSE OF THE HIGH IMPEDANCE, THE REP STATED THAT THE OLD LEAD WAS LIKELY BAD. IT WAS NOTED THAT THE HIGH IMPEDANCE HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499327 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention "SEE H10...."