AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

MDR report key: 3813635 · Received May 15, 2014

Report

Report Number: 2183959-2014-00158
Event Type: Injury
Date Received: May 15, 2014
Date of Event: November 25, 2013
Report Date: April 25, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS (MN)
Product Code: OTP
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE PC ANTERIOR, THE PATIENT EXPERIENCED MODERATE "URINARY STRESS INCONTINENCE" WITH LOSING "URINE ON COUGHING, NEEDS TO WEAR DIAPERS." THE PATIENT RECEIVED LOCAL ESTROGEN CREAM AND STARTED PELVIC FLOOR TRAINING ON (B)(6) 2013. THE EVENT IS CONSIDERED CONTINUING (NOT RESOLVED) AS OF (B)(6) 2014. THE PATIENT DOES NOT WANT SURGERY (TVT) AT THIS POINT. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STRESS URINARY INCONTINENCE THE PATIENT EXPERIENCED IS DE NOVO. AS OF (B)(6) 2014, THE INCONTINENCE IS MILD, "HAS IMPROVED", LOSING URINE "ONLY WHEN HAVING A COLD, DOES NOT WANT TVT AT THIS POINT." NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT WAS CONTINUING AS OF 04/25/2014. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290720	AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE	SURGICAL MESH	OTP	AMERICAN MEDICAL SYSTEMS (MN)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention