BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - CURVED

    MDR report key: 12930675 · Received December 4, 2021

    Report

    Report Number
    3005099803-2021-07539
    Event Type
    Injury
    Date Received
    December 4, 2021
    Date of Event
    June 6, 2018
    Report Date
    January 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A1: (B)(6). BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CORRECTION: A PREVIOUS REPORT FOR THIS PATIENT AND DEVICE HAS BEEN SENT UNDER MFR REPORT # 3005099803-2021-00057.

    Additional Manufacturer Narrative · 0

    (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SLING AND AN OBTRYX SLING WERE IMPLANTED ON (B)(6) 2010. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PERINEUM PAIN; ANAL PAIN; RECTAL PAIN; THIGH PAIN; OTHER PAIN (PUDENDAL NEURALGIA); DIFFICULTIES WITH BOWEL MOTIONS; RECURRENT INCONTINENCE; DAMAGE. SURGICAL INTERVENTIONS: ON (B)(6) 2018 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: REMOVAL OF MESH. ON (B)(6) 2018 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: TRIAL OF IMPLANT OF NEUROSTIMULATOR, SACRAL NEUROMODULATION. ON (B)(6) 2019 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: INSERTION OF NEUROSTIMULATOR PERMANENT. NONSURGICAL TREATMENTS: ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: LYRICA FOR THE TREATMENT OF: NERVE PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED INCONTINENCE MEDICATION: BETMIGA FOR THE TREATMENT OF: INCONTINENCE. ON (B)(6) 2018 THE PATIENT COMMENCED PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING) FOR THE TREATMENT OF: PAIN AND INCONTINENCE. TREATMENT DURATION: 5 MONTHS. ON (B)(6) 2019 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): BOTOX FOR THE TREATMENT OF: INCONTINENCE. TREATMENT DURATION: 1. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PALEXIA FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: NORFLEX FOR THE TREATMENT OF: PELVIC PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: DULOXETINE FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL OSTEO FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: KETAMINE INFUSION FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: EVERY 6 MONTHS. ON (B)(6) 2018 THE PATIENT COMMENCED INCONTINENCE MEDICATION: OXYTROL PATCH FOR THE TREATMENT OF: INCONTINENCE. ON (B)(6) 2019 THE PATIENT COMMENCED PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING) FOR THE TREATMENT OF: PAIN, CONDITIONING , INCONTINENCE. ON (B)(6) 2018 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): PUDENTAL NERVE BLOCK FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: X2. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: GABAPENTIN FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: 2 MONTHS. ON (B)(6) 2018 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): PULSED RADIOFREQUENCY FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: X1. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PANADEINE FORTE FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 1 YEAR. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: ENDONE FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 2 WEEKS. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: TARGIN FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 2 MONTHS. ON (B)(6) 2021 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): SACRO ILLIAC JOINT RADIOFREQUENCY FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: X2. DEVICE 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SLING AND AN OBTRYX SLING WERE IMPLANTED ON (B)(6) 2010. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PERINEUM PAIN; ANAL PAIN; RECTAL PAIN; THIGH PAIN; OTHER PAIN (PUDENDAL NEURALGIA); DIFFICULTIES WITH BOWEL MOTIONS; RECURRENT INCONTINENCE; DAMAGE SURGICAL INTERVENTIONS: ON (B)(6) 2018 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: REMOVAL OF MESH. ON (B)(6) 2018 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: TRIAL OF IMPLANT OF NEUROSTIMULATOR, SACRAL NEUROMODULATION. ON (B)(6) 2019 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT AND OBTRYX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: INSERTION OF NEUROSTIMULATOR PERMANENT. NONSURGICAL TREATMENTS: ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: LYRICA FOR THE TREATMENT OF: NERVE PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED INCONTINENCE MEDICATION: BETMIGA FOR THE TREATMENT OF: INCONTINENCE. ON (B)(6) 2018 THE PATIENT COMMENCED PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING) FOR THE TREATMENT OF: PAIN AND INCONTINENCE. TREATMENT DURATION: 5 MONTHS. ON (B)(6) 2019 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): BOTOX FOR THE TREATMENT OF: INCONTINENCE. TREATMENT DURATION: 1. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PALEXIA FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: NORFLEX FOR THE TREATMENT OF: PELVIC PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: DULOXETINE FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL OSTEO FOR THE TREATMENT OF: PAIN. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: KETAMINE INFUSION FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: EVERY 6 MONTHS. ON (B)(6) 2018 THE PATIENT COMMENCED INCONTINENCE MEDICATION: OXYTROL PATCH FOR THE TREATMENT OF: INCONTINENCE. ON (B)(6) 2019 THE PATIENT COMMENCED PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING) FOR THE TREATMENT OF: PAIN, CONDITIONING , INCONTINENCE. ON (B)(6), 2018 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): PUDENTAL NERVE BLOCK FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: X2. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: GABAPENTIN FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: 2 MONTHS. ON (B)(6) 2018 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): PULSED RADIOFREQUENCY FOR THE TREATMENT OF: NERVE PAIN. TREATMENT DURATION: X1. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: PANADEINE FORTE FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 1 YEAR. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: ENDONE FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 2 WEEKS. ON (B)(6) 2018 THE PATIENT COMMENCED PAIN MEDICATION: TARGIN FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: 2 MONTHS. ON (B)(6) 2021 THE PATIENT COMMENCED INJECTIONS (NOT ASSOCIATED WITH SURGICAL TREATMENT): SACRO ILLIAC JOINT RADIOFREQUENCY FOR THE TREATMENT OF: PAIN. TREATMENT DURATION: X2. DEVICE 2 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828915 OBTRYX SYSTEM - CURVED MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION 850-400

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention