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

Model Number	720054-02
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Irritation (1941); Pain (1994)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 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 or Problem 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 or Problem 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
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9079147
• Report Number: 2183959-2019-66232
• Device Sequence Number: 19452266
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2019

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 10/31/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 09/26/2019; 11/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR