MAUDE Adverse Event Report: BALLYMONEY - USS UNKNOWN IVS TUNNELLER DEVICE; MESH, SURGICAL, POLYMERIC

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Injury (2348); Dysuria (2684); Patient Problem/Medical Problem (2688)

Event Date 07/12/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative diagnosis: urinary incontinence.Operation: cystoscopy, ureteric stents, intravaginal sling and anterior repair.Reason for mesh implantation: urinary incontinence.Procedure (s) performed: cystoscopy, ureteric stents, intravaginal sling and anterior repair findings: the anterior incision was made by dr.(b)(6).The urethra was dissected out laterally.The stilets were passed mid urethra laterally to pre-marked sites on the suprapubic area.Complications post intravaginal sling placement: (b)(6) 2006-(b)(6) 2009: increasing right lower quadrant/right groin pain ¿ some mild obstructive lower urinary tract symptoms - mild burning dysuria ¿ her symptoms may be secondary to localized inflammation from the transvaginal tape ¿ prescribed with cipro xl 1000 mg - endoscopy ((b)(6) 2006) of her bladder reveals a well-supported bladder - x-ray of upper abdomen to the ischial tuberosities ((b)(6) 2007) revealed high density linear structure bladder lumen, consistent with calculus or foreign body -endoscopy of her bladder ((b)(6) 2007) was unremarkable ¿ the intravaginal sling on the left side for a portion of about a centimeter and a half could be seen submucosally which is unchanged - had a vaginal infection with a mucoid discharge from the vagina - treated with flagyl - vaginitis likely yeast ¿ prescribed with betnovate cream and nizoral cream 2% - cystoscopy ((b)(6) 2009) revealed just lateral to the left ureteral orifice, there was a through-and-through puncture of what is likely mesh from the tape surgery - there was stone material along this - urethroscopy was unremarkable - vaginal examination showed no erosion and good support - believe that this perforation with stone material is accounting for her pain and her recurring infections - given cipro - recommended that we remove the stone and the presumed mesh material - think that it is unlikely that this could be done well all endoscopically as the mesh would be very difficult to remove in its entirety - with her pain, think that the chance of removing this whole left limb including what is intravesical and extravesical, may give a better success at abolishing the pain.Following mesh revision, she developed erythematous rash bilateral groin with satellite lesions, bladder spasms, pelvic pain, vaginal candidiasis, recurrent uti, right sided back pain flank area, occasional stress and urge incontinence, acute diverticulosis, abdominal pain, loose bowel movement, lower abdominal wall hernia, dysuria, lower pelvic pain, urinary frequency and urgency, underwent cystoscopy on (b)(6) 2014, refractory overactive bladder symptoms, urinary irritation, strong urine odor during the time period from (b)(6) 2009 to (b)(6) 2016 and underwent the below mentioned additional implant surgery.

• Brand Name: UNKNOWN IVS TUNNELLER DEVICE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BALLYMONEY - USS; 20 garryduff road; ballymoney co.; antrim ; EI
• MDR Report Key: 5984740
• MDR Text Key: 55872953
• Report Number: 6000141-2016-00009
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: 08/31/2016; 08/08/2018
• Supplement Dates FDA Received: 07/17/2018; 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 160