BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 7631691 · Received June 22, 2018

    Report

    Report Number
    3004209178-2018-14171
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    August 4, 2005
    Report Date
    October 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3093, LOT# J0437062V, PRODUCT TYPE LEAD. PRODUCT ID NEU_PERC_EXTENSION, PRODUCT TYPE EXTENSION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093, SERIAL/LOT #: (B)(4), UBD: 14-JUL-2008; PRODUCT ID: NEU_PERC_EXTENSION, UBD: 14-JUL-2008. DEVICE CODE APPLY TO INTERSTIM, LEAD, AND EXTENSION. EVAL CODE METHOD CODES APPLY TO INTERSTIM, LEAD, AND EXTENSION. EVAL CODE-RESULT APPLIES TO INTERSTIM, LEAD, AND EXTENSION. EVAL CODE-CONCLUSION CODE APPLIES TO INTERSTIM, LEAD, AND EXTENSION. EVAL CODE-RESULT APPLIES TO INTERSTIM ONLY. EVAL CODE-RESULT APPLIES TO LEAD ONLY. EVAL CODE-RESULT APPLIES TO EXTENSION ONLY. ANALYSIS: ANALYSIS OF THE IPG 3023 INTERSTIM SINGLE CHANNEL (SERIAL# (B)(4)) FOUND NO ANOMALY. IT WAS NOTICED THAT THE IPG SE TSCREWS WERE TIGHT AND IMPRESSIONS WERE OBSERVED IN THE CONNECTOR PINS. THERE WERE BURN MARKS ON THE IPG CAN, THERE WAS A PUNCHOUT HOLE SETSCREW ON GROMMET #1, FM IN THE CONNECTOR PORTS, AND SETSCREW GROMMET #3 GROMMET HAD A CUT DEFECT. THE IPG OUTPUT WAS TESTED AT THE CUT END OF THE EXTENSION; GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. ON AN OSCILLOSCOPE ACROSS A 510 OHM LOAD, CONNECTED TO THE CUT END OF THE EXTENSION. ANALYSIS: ANALYSIS OF THE QUAD LEAD-SNS,TINED, EXTENDED E (LOT#J0437062V) FOUND THAT THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. IT WAS NOTED THAT THERE WAS BODY FLUIDS INSIDE 75% OF THE LEAD, BUT THERE WAS NO IMPACT ON THE DEVICE PERFORMANCE. IT WAS FURTHER NOTED THAT ALL FOUR CONDUCTORS ARE SLIGHTLY STRETCHED. A FUNCTIONAL TEST WAS PERFORMED ON THE LEAD WHICH CONCLUDED THAT CONTINUITY WAS ACCEPTABLE AND NO SHORTS WERE OBSERVED BETWEEN THE CIRCUITS. ANALYSIS: ANALYSIS OF THE PERCUTANEOUS EXTENSION, UNKNOWN (LOT#UNKNOWN) FOUND THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGME NTED. FOR THE PERCUTANEOUS EXTENSION FUNCTIONAL TEST, THE CONTINUITY WAS ACCEPTABLE AND NO SHORTS WERE OBSERVED. ALL FOUR CONDUCTORS AND OUTER INSULATION WERE CUT THROUGH. IT WAS FURTHER OBSERVED THAT THE BOOT IS MELTED, THE EXTENSION SETSCREWS WERE TIGHT TO THE LEAD CONNECTORS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRIOR TO THE IMDRF HARMONIZATION, THE INCORRECT CONCLUSION CODE WAS APPLIED. THE CONCLUSION CODE WAS CORRECTED AND UPDATED PER IMDRF HARMONIZATION. IN ADDITION, ALL PREVIOUSLY SUBMITTED DEVICE, METHOD, AND RESULT CODES WERE UPDATED DUE TO IMDRF HARMONIZATION. DEVICE CODES (B)(4) APPLY TO IPG (B)(4) INTERSTIM SINGLE CHANNEL (SERIAL# (B)(4) ONLY. DEVICE CODE (B)(4) APPLIES TO QUAD LEAD-SNS,TINED,EXTENDED E (LOT# (B)(4)) AND PERCUTANEOUS EXTENSION, UNKNOWN (LOT# UNKNOWN). METHOD CODE (B)(4), RESULT CODE B)(4), AND CONCLUSION CODE (B)(4) APPLY TO IPG (B)(4) INTERSTIM SINGLE CHANNEL (SERIAL# (B)(4)), QUAD LEAD-SNS,TINED ,EXTENDED E (LOT# J0437062V) AND PERCUTANEOUS EXTENSION, UNKNOWN (LOT# UNKNOWN). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCT ION/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT THE INS STOPPED WORKING AFTER 8 MONTHS. IT CAN BE NOTED THAT THE PATIENT STARTED EXERCISING SIX MONTHS AFTER IMPLANT. THE EXPLANT OCCURRED ON (B)(6) 2005 AND IT STOPPED WORKING AS A RESULT OF NORMAL BATTERY DEPLETION. THE INS WAS REPLACED. ADDITIOANL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2018. PATIENT SAID ELEVEN MONTHS AFTER THE ORIGINAL IMPLANT WAS DONE, THEY HAD TO REPLACE IT BECAUSE THE LEADS PULLED OUT FROM SOMETHING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471930 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention