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

Model Number	720074-01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that due to migration the patient will have his spectra concealable penile prosthesis (spp) revised on a future date.The patient was discharged 60 postoperative days for sexual initiation.After 2 weeks the patient noticed a migration of the prothesis.After consultation it was noted that the prosthesis left side was positioned 4 cm below the end of the cavernous body in its distal portion.Should additional information be received a supplemental report will be submitted.It was further reported that this patient is experiencing a lot of pain.
Event or Problem Description
It was reported that due to migration the patient will have his spectra concealable penile prosthesis (spp) revised on a future date.The patient was discharged 60 postoperative days for sexual initiation.After 2 weeks the patient noticed a migration of the prothesis.After consultation it was noted that the prosthesis left side was positioned 4 cm below the end of the cavernous body in its distal portion.Should additional information be received a supplemental report will be submitted.It was further reported that this patient is experiencing a lot of pain.It was further reported that this patient has his spp removed and replaced.A new 12mmx20cm spp was implanted.
Additional Manufacturer Narrative
Correction to b5, d7, and h6: updated to include additional information h3 other text : device not returned for evaluation.

• 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: 8861435
• Report Number: 2183959-2019-65496
• Device Sequence Number: 513953
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 03/17/2022
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 0170498003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR