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

Model Number 720054-02

Device Problem Defective Device (2588)

Patient Problems Irritation (1941); Pain (1994)

Event Date 09/05/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and inconvenience with a spectra penile prosthesis (spp).The spp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Manufacturer Narrative

Device analysis: pain and patient dissatisfaction were reported.The spectra cylinders were visually inspected and functionally tested.Both cylinders performed within specifications.The product analysis did not confirm the allegations of pain and patient dissatisfaction.Based on the results of this investigation, no escalation is necessary.

Event Description

It was reported that the patient experienced pain and inconvenience with a spectra penile prosthesis (spp).The spp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that the pain began 3 weeks prior to revision surgery and was located at the contact location of the distal tip of the cylinder.The patient was also experiencing some irritation in the area of pain.

Event Description

It was reported that the patient experienced pain and inconvenience with a spectra penile prosthesis (spp).The spp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that the pain began 3 weeks prior to revision surgery and was located at the contact location of the distal tip of the cylinder.The patient was also experiencing some irritation in the area of pain.

• 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: 9079147
• MDR Text Key: 158896276
• Report Number: 2183959-2019-66232
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2016
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 750953004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR