MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 720054-02

Device Problems Mechanical Problem (1384); Defective Device (2588); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that the 9.5mmx16cm spectra penile prosthesis is too malleable, patient did not have the expected erection for intercourse, and a cracking sound is heard when bending the prosthesis after intercourse.Device remains implanted.As the complaint component remains implanted and the product record review revealed no additional information related to the complaint, an overall investigation conclusion code of no problem detected was chosen as the device problem cannot be confirmed.As the reported problem could not be confirmed, the event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.

Manufacturer Narrative

Additional information, device analysis.

Event Description

Additional information the reason for the cracking sound was unclear and may be due to a malfunction.The penis bends during intercourse, does not maintains full erection.As the complaint component remains implanted and the product record review revealed no additional information related to the complaint, an overall investigation conclusion code of no problem detected was chosen as the device problem cannot be confirmed.As the reported problem could not be confirmed, the event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.

Manufacturer Narrative

No intervention had occurred to date.

Event Description

Additional information the reason for the cracking sound was unclear and may be due to a malfunction.The penis bends during intercourse, does not maintains full erection.As the complaint component remains implanted and the product record review revealed no additional information related to the complaint, an overall investigation conclusion code of no problem detected was chosen as the device problem cannot be confirmed.As the reported problem could not be confirmed, the event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 7938625
• MDR Text Key: 123247674
• Report Number: 2183959-2018-60021
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2021
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 0141111005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR