AMX 700 CX UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-08 for AMX 700 CX UNKNOWN manufactured by American Medical Systems.

Event Text Entries

[3655181] Penile prosthesis failed, surgically removed in or. Patient has a history of rectal cancer s/p resection including partial cystectomy due to invasion of rectal cancer into bladder, permanent colostomy and inflatable penile prosthesis (ipp) placement. Initial ipp placed about 11 years ago, reports that there was a lead and the prosthesis failed and therefore it was removed and replaced about 5 years ago. Operative note indicates that he currently has an ams 700 cx implant in place. Notes that the prosthesis worked great initially and that in the last 6 months he has noticed that his penis curves to the right, greater when the prosthesis is inflated. Denies known trauma or vigorous sexual activity that precipitated the curvature. In the or: device was pumped up and veering quite a bit to the right. Corporotomy was performed and it was evident on both sides that we first encountered the middle dacron layer, the cylinder indicating loss of containment of the external silicone sheath. Nevertheless, we were able to identify the frayed edge of the silicone sheath on the right side and rather easily pulled this device out. On the left side, the dacron was stuck to surrounding tissue and required a fair amount of force to pull out. We knew from previous records that this was an ams 700 device with 21 centimeters cylinders and 7 centimeters rear tip extenders on the right and six on the left. Once removing the components, all rear tip extenders were identified. There was teflon present but had been incorporated completely within the corporotomy creating a situation of silicone tubing rubbing on the silicone outer sheath, possibly the reason for the breech of the silicone outer sheath. Once pulling the device out, we were able to reduce the silicone sheath which had accordioned down the corporal bodies, more on the left than the right and it appeared that all components of the outer silicone sheath were accounted for. What was the original intended procedure? Inflatable penile prosthesis. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3220884
• MDR Report Key: 3220884
• Date Received: 2013-07-08
• Date of Report: 2013-06-26
• Date of Event: 2013-04-25
• Report Date: 2013-06-26
• Date Reported to FDA: 2013-07-08
• Date Reported to Mfgr: 2013-07-11
• Date Added to Maude: 2013-07-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMX 700 CX
• Generic Name: PROSTHESIS, PENILE
• Product Code: JCW
• Date Received: 2013-07-08
• Model Number: AMX 700 CX
• Catalog Number: UNKNOWN
• Lot Number: UNK
• ID Number: *
• Device Availability: Y
• Device Age: 5 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS
• Manufacturer Address: 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-08