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

Model Number 72404013

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Model number: 72400152, lot number: 683351002, model description: reservoir 65 ml.Model number: 72401110, lot number: 631732001, model description: pump cxm.

Event Description

It was reported that the patient underwent a surgical procedure to implant a new inflatable penile prosthesis (ipp) for unspecified reasons.The existing ipp was removed and replaced with a new device.There were no patient complications reported.No further information is available at this time.Additional information was received indicating the ipp was explanted as it no longer functioned beginning approximately 2 months prior to the revision procedure.The patient was reported to be doing well after the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9131699
• MDR Text Key: 160448772
• Report Number: 2183959-2019-66427
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002705
• UDI-Public: 00878953002705
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2015
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 657209004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR