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

Model Number	72404234
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related components of device system: model number/ catalog number: 720185-01; serial number: n/a; batch/ lot number: 1000081467; model/ catalog description: reservoir flat iz 100 ml.
Event or Problem Description
It was reported that the patient underwent an infallible penile prosthesis (ipp) due to the reservoir herniated out f space and the pump was high riding in the patient's scrotum.The reservoir and pump were removed and replaced.The patient had a good outcome.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.Additional information received.The patient presented a bulge in the abdomen due to the herniated reservoir and had difficulty cycling his device because of his high riding pump.
Additional Manufacturer Narrative
Product analysis could not confirm a malfunction related to the reported events.The product record review indicated that the product met all in-process specifications prior to leaving bsc and the reported events do not represent an unanticipated event.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The pump functional failure could indicate that the pump functionality was reduced, but is not related to the alleged migration of the pump within the body.The product analysis did not confirm the allegation of pump migration because the necessary patient anatomical detail is unknown.Product analysis did not confirm a reservoir malfunction.Product analysis cannot confirm the reservoir migration.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.Related components of device system: model number/ catalog number: 720185-01 serial number: n/a batch/ lot number: 1000081467 model/ catalog description: reservoir flat iz 100 ml.
Event or Problem Description
It was reported that the patient underwent an infallible penile prosthesis (ipp) due to the reservoir herniated out f space and the pump was high riding in the patient's scrotum.The reservoir and pump were removed and replaced.The patient had a good outcome.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.Additional information received.The patient presented a bulge in the abdomen due to the herniated reservoir and had difficulty cycling his device because of his high riding pump.

• 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: 9218348
• Report Number: 2183959-2019-67032
• Device Sequence Number: 2733793
• Product Code: FHW
• UDI-Device Identifier: 00878953003474
• UDI-Public: 00878953003474
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/11/2018
• Device Model Number: 72404234
• Device Catalogue Number: 72404234
• Device Lot Number: 0152329001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR