BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3004209178-2018-17482

    MDR report key: 7753469 · Received August 6, 2018

    Report

    Report Number
    3004209178-2018-17482
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    June 13, 2018
    Report Date
    November 16, 2018
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID 3889-28 LOT# VA1MPKX SERIAL# IMPLANTED: 2018-(B)(6)EXPLANTED: 2018-(B)(6) PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA1MPKX, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: VA1MPKX, UBD: 15-DEC-2021, (B)(4). 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NO NEW INFORMATION WAS REPORTED; HOWEVER, IT WAS PREVIOUSLY REPORTED THAT THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) FOR A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THERE WAS AN INTERSTIM SURGICAL SITE INFECTION. IT WAS NOTED THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6). THE HCP NOTED THE PATIENT HAD PAIN AT THE INCISION SITE ON (B)(6) AND MEDICATIONS WERE ADMINISTRATED ON (B)(6). THE HCP STATED ON (B)(6) THE PATIENT CAME BACK AND STATED THE PAIN HAD MIGRATED TO DOWN THE LEAD. THE HCP NOTED THERE WAS ERYTHEMA MIGRATING FROM THE LEAD SITE TO THE INCISION ON THE LEFT BUTTOCK. THE HCP STATED THERE WAS PAIN, HEAT, AND CELLULITIS ON (B)(6). THE HCP STATED THERE WAS WARMNESS TO PALPATION AND CHILLS. THE EVENT RESULTED IN PATIENT HOSPITALIZATION, EMERGENCY ROOM VISIT, AND AN UNSCHEDULED CLINIC OR OFFICE VISIT. IT WAS NOTED THE ISSUE WAS RESOLVED WITH SEQUELAE ON (B)(6) 2018. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY AND WAS RELATED TO THE IMPLANT PROCEDURE AND THE NEUROSTIMULATOR POCKET AND THE LEAD INTRODUCER SITE. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R