MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	1008299
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device: model number/catalog number 720182-01, serial number (b)(4), batch/lot number 178272008, gtin (b)(4).Model/catalog description reservoir flat 100 ml, expiration date 06/21/2022, manufacturer date 06/21/2017.
Event or Problem Description
It was reported that the patient presented with thinning of the penis and an inflated implant without axial stiffness with a fold in the middle resulting in a nonfunctional penis new scheduled surgery and the procedure will be the reconstruction of the cavernous bodies and exchange of penile prosthesis.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8663239
• Report Number: 2183959-2019-63627
• Device Sequence Number: 13982761
• Product Code: FHW
• UDI-Device Identifier: 00878953005713
• UDI-Public: 00878953005713
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/18/2018
• Device Model Number: 1008299
• Device Catalogue Number: 1008299
• Device Lot Number: 839720004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1
• Patient Age: 46 YR