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

Model Number 720074-02

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 11/01/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced unspecified issues with a spectra penile prosthesis (spp).The spp were explanted and a new 18cmx12mm implantable penile prosthesis (ipp) were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: patient dissatisfaction, model number and batch/lot number, implant date.

Event Description

It was reported that the patient experienced dissatisfaction with a spectra penile prosthesis (spp).The spp were explanted and a new 18cmx12mm implantable penile prosthesis (ipp) were implanted.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8130849
• MDR Text Key: 129257554
• Report Number: 2183959-2018-61287
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2021
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 0139335002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR