BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 5952410 · Received September 15, 2016

    Report

    Report Number
    3004209178-2016-18966
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    December 14, 2006
    Report Date
    October 11, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377860, LOT# V008569, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V013243, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377860, LOT# V008569, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V013243, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE KEEPS THE STIMULATION LOW BECAUSE THE LEADS GO TO VAGINAL AREA. IF THE PATIENT TURNS IT UP IT TIGHTENS UP HER LEGS, THIS OCCURRED ON (B)(6) 2006. IF THE PATIENT SITS A LONG TIME SHE HAS TO INCREASE IT. IT WAS NOTED THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP). THE INDICATION FOR USE INCLUDED OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2016 REPORTED THAT SHE COULD NOT EXPLAIN WHAT CIRCUMSTANCES LED TO THE LEADS GOING TO THE VAGINAL AREA AND INCREASING THE STIMULATION TIGHTENING UP THE PATIENT'S LEGS. THE PATIENT NOTED THAT IT HAD BEEN THAT WAY FOR A COUPLE MONTHS, BUT NOW THE BATTERY WAS GETTING LOW. STEPS TAKEN TO RESOLVE THE ISSUES INCLUDED SURGERY TO CHANGE TO NEW LEADS ON (B)(6) 2016. IT WAS NOTED THAT THE ISSUES RESOLVED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604852 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention