APOGEE

MDR report key: 2861844 · Received November 27, 2012

Report

Report Number: 2183959-2012-03033
Event Type: Injury
Date Received: November 27, 2012
Date of Event: September 10, 2012
Report Date: November 6, 2012
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
Product Code: FTL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

Description of Event or Problem · 1

RELATED TO MFR REPORT # 2183959-2012-03034, 03037. IT WAS REPORTED THAT AN APOGEE DEVICE WAS IMPLANTED, THE DATE OF IMPLANT WAS NOT PROVIDED. SHE HAD IMMEDIATE SEVERE POST-OPERATIVE PAIN AFTER SURGERY AND WAS TAKEN BACK TO THE OPERATING ROOM FOR ADJUSTMENT. SHE THEN HAD A SECOND PROCEDURE WHERE THE MESH ARMS WERE TRANSACTED AND STITCHES WERE REMOVED FROM THE SACROSPINOUS LIGAMENT. SHE CONTINUED TO HAVE PERSISTENT PAIN, GREATER ON THE LEFT SIDE. ON EXAMINATION IN THE OFFICE, MESH WAS PALPABLE IN SOME AREAS WITH TENDERNESS OVERLYING THE SACROSPINOUS LIGAMENT. IN THE OPERATING ROOM, THERE WAS "DISTAL MESH UNDERNEATH THE VAGINA," BUT NO MESH WAS PALPATED NEAR THE UTEROSACRAL LIGAMENTS. DURING DISSECTION ON THE LEFT, THE SURGEON ENCOUNTERED "MESH OVERLYING THE SACROSPINOUS AT THE LEVEL OF THE ISCHIAL SPINE THAT WAS AFFIXED" AND THERE WAS "APPROX A CENTIMETER OF BALLED UP MESH" THAT WAS EXCISED. THE ENTIRE RIGHT AND LEFT SACROSPINOUS LIGAMENTS WERE EXPOSED AND THERE WERE NO MESH OR SUTURES. CYSTOSCOPY AT THE END OF THE PROCEDURE WAS NORMAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	APOGEE	SURGICAL MESH	FTL	AMERICAN MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Hospitalization\| R	PERIGEE\| MONARC SLING SYSTEM