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

Model Number UNK-P-SPP

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  Injury  

Event Description

It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp) due to device was malfunctioning 6 years after implant.There was a fluid loss.Additional information was received.There was a hole in the cylinder wall.It was visually confirmed when the device was explanted.

Manufacturer Narrative

Field change: h3,h6,h10.The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp) due to device was malfunctioning 6 years after implant.There was a fluid loss.Additional information was received.There was a hole in the cylinder wall.It was visually confirmed when the device was explanted.Additional information was received.Patient experienced dissatisfaction.Additional information was received.The explanted component was a spectra penile prosthesis (spp) that was upgraded to an inflatable penile prosthesis (ipp).

Event Description

It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp) due to device was malfunctioning 6 years after implant.There was a fluid loss.Additional information was received.There was a hole in the cylinder wall.It was visually confirmed when the device was explanted.Additional information was received.Patient experienced dissatisfaction.Additional information was received.The explanted component was a spectra penile prosthesis (spp) that was upgraded to an inflatable penile prosthesis (ipp).

• 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: 9560078
• MDR Text Key: 173996848
• Report Number: 2183959-2019-68543
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953003443
• UDI-Public: 00878953003443
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• 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: 03/05/2020

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: 08/08/2014
• Device Model Number: UNK-P-SPP
• Device Catalogue Number: UNK-P-SPP
• Device Lot Number: 784636005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/20/2020; 02/14/2020
• Supplement Dates FDA Received: 02/10/2020; 03/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR