MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

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

Patient Problems Diarrhea (1811); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Pain (1994); Swelling (2091); Anxiety (2328); Depression (2361); Dyskinesia (2363); Dysuria (2684); Constipation (3274)

Event Date 08/11/2014

Event Type  Injury  

Event Description

It was reported that following the implantation of the miniarc sling, the patient experienced "a fibromyalgia flare which was the reason for all this pain" and that her "pelvic and abdomen were spasming".The patient also alleged that she "could barely walk and was in excruciating pain", prescribed medication but that she can "still feel all the pain despite these two medications", "can't sit, walk, stand, lay down without pain", cannot perform activities of daily living, and generalized weakness.The patient also alleged that she experienced "herniated disk", "trouble urinating, painful urination like burning, pubic bone pain, pelvic/abdominal pain, feels like muscles are pulling, hip pain, back pain, neck pain, electrical shocks throughout my elbows, entire arms/both feet (i now walk with a limp), headaches like migraines, tired all the time, can't concentrate, emotional problems, depression, loss of confidence/self-worth", bowel problems, "diarrhea, constipation, very swollen abdomen, acid reflux, swollen feet, anxiety and panic attacks, broken out hives/skin rashes", and "pain feels like knives cutting inside me".The mesh was removed and the patient alleged that she experienced residual symptoms from the mesh "abdominal pain, it feels like muscles are pulling, hip pain, back pain, neck pain, fatigued, neuromuscular problems-muscle weakness in hands fingers, elbows, my entire arms, tired all the time, can't concentrate, emotion problems, depression, problems going to poop swell belly getting worse not better, anxiety and panic attacks, problem with liver, possible thyroid problem".There were no further patient complications were reported in relation to this event.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4906073
• MDR Text Key: 6836983
• Report Number: 2183959-2015-00295
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention