BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3111680 · Received April 10, 2013

    Report

    Report Number
    9615742-2013-00243
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 25, 2008
    Report Date
    February 26, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MEDTRONIC COMPLAINT REPORT: (B)(64. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, REASON/ INDICATION FOR MESH IMPLANTATION: MIXED URINARY INCONTINENCE. PROCEDURE (S) PERFORMED: SYNTHETIC PUBOVAGINAL SLING, CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. POSTOPERATIVE COMPLICATIONS: COMPLICATIONS POST IMPLANTATION: REFRACTORY URINARY URGENCY, URINARY FREQUENCY, URGE INCONTINENCE FIRST ADDITIONAL SURGERY: (B)(6) 2008: UNDERWENT IMPLANTATION OF A TINED LEAD FOR SACRAL NEUROMODULATION FOR REFRACTORY URGENCY, FREQUENCY AND URGE INCONTINENCE UNDER GENERAL ANESTHESIA. COMPLICATION POST FIRST ADDITIONAL SURGERY: (B)(6) 2008: REFRACTORY URGENCY, FREQUENCY, AND URGE INCONTINENCE STATUS POST SUCCESSFUL RESPONSE WITH TEST SIMULATION. DIAGNOSIS OF OPERATIVE REPORT SECOND ADDITIONAL SURGERY: (B)(6) 2008: UNDERWENT IMPLANTATION AND PROGRAMMING OF IPG (IMPLANTABLE PULSE GENERATOR) FOR SACRAL NEUROMODULATION FOR REFRACTORY URGENCY, FREQUENCY, AND URGE INCONTINENCE STATUS POST SUCCESSFUL RESPONSE WITH TEST SIMULATION UNDER GENERAL ANESTHESIA. COMPLICATIONS POST SECOND ADDITIONAL SURGERY: (B)(6) 2014: DIFFICULTY WITH VOIDING AND EMPTYING AND HAVING TO STRAIN. REPORT NOT AVAILABLE). PELVIC PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152388 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SHJ00290

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other