MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH LYNX SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number UNK564

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Urinary Retention (2119); Burning Sensation (2146); Dysuria (2684)

Event Date 04/01/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx sling was implanted in a patient with a prolapsed bladder as well as stress urinary incontinence.On (b)(6), 2010.According to the complainant, post procedure, the patient experienced immediate discomfort.The physician attributed this to other causes.Eight weeks later, the patient was admitted to the hospital due to extreme pain.She was treated with intravenous medication but it didn't help alleviate her pain.Exploratory procedure was done to check the mesh and it was noted to be fine.However, the pain worsened.Patient could not sit at all, stand for more than a minute, and walk.She catheterized herself as she could not urinate on her own.Four months post implant, the patient was bedridden due to pain and was getting weaker.Five months later, the mesh was removed.Her urethral pain immediately subsided and she can normally urinate again.But, she can still feel pain on her vagina.Patient went to a physical therapist who diagnosed her with pelvic muscle spasm and was told that the tightest point was where the mesh had been attached.After seven months of internal physical therapy, multiple weekly nerve blocks by a pain specialist, and seven different pain medications, patient finally felt an improvement with her condition.Despite this, patient was left with burning, stinging, and sharp pain on one side of her vaginal wall.Her pain doctor diagnosed her with vulva neuroma which she had surgically removed.Twelve months after implant, patient had to go back to physical therapy to loosen her pelvic muscles again.Another five months later, patient still had some vaginal pain and swelling.She was unable to sit or have sex.Another surgeon diagnosed her with pelvic congestion syndrome with symptoms of puffy, swollen, painful, and with varicose veins in her vulva.Patient had two more surgeries to treat her condition.Currently, patient is still in pain that needs pain medications but not as bad as when the mesh was still implanted.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.Voluntary user medwatch number is mw5036014.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3913454
• MDR Text Key: 4663366
• Report Number: 3005099803-2014-02454
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention