BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    MDR report key: 3162935 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10132
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    August 15, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2011 DUE TO CHRONIC PELVIC PAIN, SUI AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BOWEL PROBLEMS, DYSPAREUNIA, ELECTRICAL SHOCK TO RIGHT OVARY AT INCISION. IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HYSTERECTOMY W/ REVISION OF PELVIC MESH SLING ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A DIAGNOSTIC LAPAROSCOPY AND PLACEMENT OF SYNTHETIC SUBURETHRAL SLING DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY/BSO ON (B)(6) 2013 DUE TO CHRONIC PELVIC PAIN AND DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT SPHINCTEROTOMY ON (B)(6) 2012 DUE TO INTERNAL HEMORRHOIDS. THE PATIENT UNDERWENT ROBOTIC RECTOPEXY ON (B)(6) 2014 DUE TO RECTAL PROLAPSE. THE PATIENT UNDERWENT PARTIAL MESH RESECTION ON THE LEFT SIDE ON (B)(6) 2014 DUE TO CHRONIC PELVIC PAIN LEFT LEVATOR ANI MUSCLE SPASM, AND POSSIBLE SUBURETHRAL SLING MESH RETRACTION INTO THE LEVATOR ANI MUSCLE GROUP OR TENDON. ON (B)(6) 2014, THE PATIENT UNDERWENT PUDENDAL NERVE BLOCK, BILATERAL DUE TO NERVE ROOT DISORDER, AND ANAL PAIN. ON (B)(6) 2015, THE PATIENT UNDERWENT BILATERAL PUDNEDAL NERVE BLOCKS, PELVIC FLOOR TRIGGER POINT INJECTION WITH BOTOX, BILATERAL DUE TO CHRONIC PELVIC PAIN, SEVERE PELVIC FLOOR SPASM, AND PELVIC FLOOR MYALGIA. THE PATIENT UNDERWENT IMPLANTATION OF TINED ELECTRODE AT THE PUDENDAL NERVE BILATERALLY THROUGH THE LESSER SCIATIC FORAMEN AS A MEANS OF SACRAL AND PERIPHERAL NEUROMODULATION WITH INTRAOPERATIVE PROGRAMMING FLUOROSCOPY AND EMG MONITORING AND PLACEMENT OF ST. JUDE IPG ON (B)(6) 2015 DUE TO SEVERE URGE INCONTINENCE, URGENCY FREQUENCY, SEVERE PUDENDAL NEURALGIA, INTRACTABLE PERIPHERAL NERVE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261852 GYNECARE TVT EXACT CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3510384

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention