BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY

    MDR report key: 6022137 · Received October 12, 2016

    Report

    Report Number
    3007566237-2016-03548
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    May 30, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3531, LOT# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR REPORTED THAT THE PATIENT OUTCOMES WERE DEPENDENT UPON WHICH ARM OF THE STUDY THE PATIENTS WERE ALLOCATED TO. IN REGARDS TO THE PREVIOUSLY REPORTED INFECTIONS, THE AUTHOR STATED ONE OF THOSE PATIENTS HAD BEEN RE-IMPLANTED WITH A NEW ELECTRODE. ADDITIONALLY, THE AUTHOR REPORTED THAT ONE PATIENT IN THE ARTICLE HAD REQUIRED EXPLANT DUE TO PAIN AFTER 12 MONTHS FOLLOW-UP.

    Description of Event or Problem · 1

    RYDNINGEN, M.B., DEHLI, T., WILSGAARD, T., LINDSETMO, R.O., KUMLE, M., STEDENFELDT, M., NORDERVAL, S. SACRAL NEUROMODULATION FOR FAECAL INCONTINENCE FOLLOWING OBSTETRIC SPHINCTER INJURY - OUTCOME OF PERCUTANEOUS NERVE EVALUATION. COLORECTAL DISEASE : THE OFFICIAL JOURNAL OF THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 2016. DOI 10.1111/CODI.13472 SUMMARY: THE PURPOSE OF THIS STUDY WAS TO ASSESS THE EFFICACY OF PERCUTANEOUS NERVE EVALUATION (PNE) IN WOMEN WITH FAECAL INCONTINENCE (FI) FOLLOWING OBSTETRIC ANAL SPHINCTER INJURY AND RELATE THE OUTCOMES TO BASELINE FACTORS WITH SPECIAL EMPHASIS ON THE EXTENT OF SPHINCTER DEFECT. REPORTED EVENTS: 2 PATIENTS UNDERWENT PERIPHERAL NERVE EVALUATION (PNE) FOR FECAL INCONTINENCE. THE PATIENTS REQUIRED THE TINED LEAD TO BE REMOVED DUE TO INFECTION WITH STAPHYLOCOCCUS AUREUS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: TINED LEAD MODEL 3093; EXTERNAL NEUROSTIMULATOR VERIFY MODEL 3531; PATIENT CONTROLLER MODEL 3537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673006 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention