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

Model Number	72404172
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspect medical device, device manufacture date: cylinder: (b)(4).Batch/lot #: 0173610002.Mfg date: 05/16/2017.Exp date: 04/29/2019.
Event or Problem Description
It was reported that an inflatable penile prosthesis (ipp) was revised due to patient dissatisfaction of not stiff enough.The cylinder was removed and replaced.No patient complications were reported in relation to this event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.
Additional Manufacturer Narrative
The product record review revealed no additional information related to the complaint so an overall investigation conclusion code of no problem detected was chosen as the reported device problem cannot be confirmed.The reported allegation(s) could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.Suspect medical device, device manufacture date: cylinder: gtin# (b)(4), upn# 72404172, batch/lot # 0173610002, mfg date 05/16/2017, exp date 04/29/2019.
Event or Problem Description
It was reported that an inflatable penile prosthesis(ipp) was revised due to patient dissatisfaction of not stiff enough.The cylinder was removed and replaced.No patient complications were reported in relation to this event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8144649
• Report Number: 2183959-2018-61479
• Device Sequence Number: 949865
• Product Code: FHW
• UDI-Device Identifier: 00878953003269
• UDI-Public: 00878953003269
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: Health Professional
• Device Expiration Date: 04/29/2019
• Device Model Number: 72404172
• Device Catalogue Number: 72404172
• Device Lot Number: 0173610002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 05/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 29 YR