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

Catalog Number SEE H10

Device Problems Inflation Problem (1310); Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: model number: 72403340, lot number: 525241006, model description: cx pre-connect 21cm ps; model number: 72400152, lot number: 704265001, model description: reservoir, 65ml.

Event Description

It was reported the patient had is inflatable penile prosthesis (ipp) implanted (b)(6) 2011.The patient's device has not been inflating anymore for the last 30 days.The patient's device was observed under magnetic resonance and it was determined there was "a problem with the right cylinder." additional information was received stating the ipp was replaced on (b)(6) 2018 due to "cylinder over expanded not in normal shape." this complaint was initially submitted to fda via asr report q3 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 8292763
• MDR Text Key: 134596421
• Report Number: 2183959-2019-00010
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR