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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. APOGEE SYSTEM WITH INTEPRO LITE SURGICAL MESH

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AMERICAN MEDICAL SYSTEMS, INC. APOGEE SYSTEM WITH INTEPRO LITE SURGICAL MESH Back to Search Results
Event Type  Injury  
Event Description

Related to mfr report # 2183959-2012-02512. Related to mfr report # 2183959-2012-02514. It was reported by the plaintiff's attorney that on or about (b)(6) 2009 the plaintiff was implanted with a apogee system with intepro lite "to treat her pelvic organ prolapse and urinary incontinence". It was alleged that the plaintiff "has suffered severe and permanent bodily injuries and significant mental and physical pain and suffering", "has sustained permanent injury, has undergone medical treatment", "will likely undergo corrective surgery and hospitalization", and has had other injuries. It was also alleged that "in many cases, including plaintiff's, the women have been forced to undergo extensive medical treatment, including, but not limited to, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of pelvis, spine, and the vagina, and operations to remove portions of the female genitalia".

 
Manufacturer Narrative

Should additional info become available regarding this event it will be re-evaluated and a f/u report will be sent.

 
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Brand NameAPOGEE SYSTEM WITH INTEPRO LITE
Type of DeviceSURGICAL MESH
Manufacturer (Section F)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka MN 55343
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka MN 55343
Manufacturer Contact
randy hoyt, sr. mgr
10700 bren rd., west
minnetonka , MN 55343
(952) 930 -6277
Device Event Key2753181
MDR Report Key2722660
Event Key2619256
Report Number2183959-2012-02513
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer,Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2012
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
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/14/2012
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
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/29/2012 Patient Sequence Number: 1
Treatment
SPARC SLING SYSTEM
PERIGEE SYSTEM WITH INTEPRO LITE
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