MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720074-02

Device Problem Mechanical Problem (1384)

Patient Problems Cellulitis (1768); Ecchymosis (1818); Edema (1820); Fever (1858); Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Nausea (1970); Pain (1994); Renal Failure (2041); Urinary Retention (2119); Ventricular Tachycardia (2132); Vomiting (2144)

Event Date 04/17/2014

Event Type  Injury  

Event Description

It was reported that the patient's spectra "prosthesis will not retain their rigidity"."the patient feels that the center rod/wire may have become dislodged or broken loose".The device remains implanted.No further patient complications were reported in relation with this event.

Event Description

It was further reported that following the implantation of the device, the patient experienced scrotal edema, ecchymosis, nausea and vomiting.The patient was voiding without difficulty and discharged on (b)(6) 2013 with persistent edema.The patient developed retention and had a catheter placed by a "visiting nurse." the patient experienced "increasing discomfort" and he was admitted to the hospital on (b)(6) 2013 with a fever.The patient was subsequently found to have induration with scrotal cellulitis and elevated white blood cell count.The patient was started on iv antibiotics.The patient experienced pain, discomfort, urination problems, and was found to have scrotal hematoma and post procedure phimosis and infection."the patient also had acute-on-chronic renal failure" and "episode of nonsustained v-tach for which cardiology was consulted".The patient was discharged on (b)(6) 2013 with medication.At a (b)(6) 2015 follow-up doctor visit, the "patient states his implant has not worked since it was placed".The physician noted that the prosthesis is "functional" and recommended that the patient "lose weight" and "leave the prosthesis alone".No further complications were reported in relation with this event.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road 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: 3826586
• MDR Text Key: 4399353
• Report Number: 2183959-2014-00170
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2018
• Device Catalogue Number: 720074-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: 91 YR
• Patient Weight: 122