MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720056-02

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); No Information (3190)

Event Type  Injury  

Event Description

It was reported the patient had his spectra penile prosthesis removed for unspecified reasons.No patient complications were reported in relation to this event.

Event Description

Additional information received indicated the device was replaced due to "detachment from pubic bone." there was "no axial rigidity due to detachment.".

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7516115
• MDR Text Key: 108319061
• Report Number: 2183959-2018-00064
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2020
• Device Catalogue Number: 720056-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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