MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Catalog Number 72404237

Device Problems Inflation Problem (1310); Mechanical Problem (1384); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Anxiety (2328); Depression (2361)

Event Date 04/29/2013

Event Type  Injury  

Manufacturer Narrative

This event was previously submitted on the ams q2 2014 asr as with reference number (b)(4).New information was received on january 27, 2016 which prompted an emdr to be submitted.

Event Description

It was reported that the patient had an ams700 inflatable penile prosthesis (ipp) device implanted and that on (b)(6) 2013 an x-ray function test was performed that discovered a dislocation of the distal cylinder segment of the patient's right side.On (b)(6) 2013 an operation was performed to correct this issue.On (b)(6) 2013 the indwelling catheter was removed and the device was noted to be in the correct position and functioning.The patient was discharged on (b)(6) 2013 in "good general condition and with irritation-free wound condition." it was further reported on (b)(6) 2016 that after the original implant of the device and one months usage the ipp would "lose pressure after it was pumped up." the plaintiff was seen at a clinic in 2012 and reported the malfunction.An examination was performed and the plaintiff was informed that the pump was functioning properly.However, the "functioning of the pump became appreciably impaired, to the point that it was practically without effect by the beginning of 2013, as the loss in pressure became ever more rapidly evident." the plaintiff was seen at the same clinic on (b)(6) 2013 and no fault in the design was detected by the physicians.On (b)(6) 2013 the plaintiff visited a different clinic and a scan revealed that ".Although the pump had been correctly installed, a spontaneous loss of fluid from both cavernous bodies took place just a short time after they had pumped up completely, with a corresponding increased degree of filling of the reservoir balloon." the ipp pump was removed and a new pump was implanted during surgical procedures on (b)(6) 2013 and (b)(6) 2013."the pump functions since then without malfunction and to the complete satisfaction of the complainant." the plaintiff "was massively affected by the failure of the pump in which the plaintiff had set all of his hopes.This expressed itself in a considerable worsening of his psychological state.The plaintiff suffered increasingly from depression.The family life of the plaintiff, which was affected as well by his misery, suffered a very great damage as a result." the legal document states that the malfunction "led to an increasing worsening of the psychological state of his pathology as manifested by an adaptation disorder with prolonged depressive reaction." "these negative disease consequences were caused by the defect in the prosthesis.The plaintiff would otherwise have been spared the depressive illness that took place over a period of more than two years." it is also to be assumed, that due to the prolonged period of functional incapacity, the illness has now become chronic in nature, or at least latently present.At any rate, the plaintiff must now live with the constant anxiety of having to cope with another failure of the device." there were no further patient complications reported as a result of this event.

Manufacturer Narrative

Corrected: common device name from penile prosthesis to device, impotence, mechanical/hydraulic.Product code (fda) from fae to fhw.The pma/510(k) from k821628 to n970012.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5444751
• MDR Text Key: 38475958
• Report Number: 2183959-2016-00079
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2011
• Device Catalogue Number: 72404237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR