MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404287
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Codes	Anxiety (2328); Deformity/ Disfigurement (2360)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented floppy glans and the device not working as intended due to inflation issues.The patient stated he felt he was not properly educated or given clear expectations.In addition, he felt misled by the materials and resources provided prior to the operation.When device is fully inflated, the distal cylinder tips are 1.5 in below the tip of his penis and are uneven in length.However, the patient services specialist verified that the corporal measurements align with the implanted cylinder and rear tip extenders.The patient consulted a urologist, but since he does not specialize in ipps, and indicated that he would pass the information to the implant physician; however, the patient has not received any follow-up from either doctor and is increasingly anxious.Patient services specialist suggested an appointment with the implant physician or trying to see a different urologist for device evaluation.No further information was provided.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented floppy glans and the device not working as intended due to inflation issues.The patient stated he felt he was not properly educated or given clear expectations.In addition, he felt misled by the materials and resources provided prior to the operation.When device is fully inflated, the distal cylinder tips are 1.5 in below the tip of his penis and are uneven in length.However, the patient services specialist verified that the corporal measurements align with the implanted cylinder and rear tip extenders.The patient consulted a urologist, but since he does not specialize in ipps, he indicated that he would pass the information to the implant physician; however, the patient has not received any follow-up from either doctor and is increasingly anxious.Patient services specialist suggested an appointment with the implant physician or trying to see a different urologist for device evaluation.No further information was provided.
Additional Manufacturer Narrative
Additional information updated: h6: evaluation conclusion codes.

• Brand Name: AMS 700 CX MS PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21102249
• Report Number: 2124215-2024-82043
• Device Sequence Number: 8657351
• Product Code: JCW
• UDI-Device Identifier: 00878953003900
• UDI-Public: 00878953003900
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: Lay User/Patient
• Device Model Number: 72404287
• Device Catalogue Number: 72404287
• Device Lot Number: 1100458551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720182-01 / LOT: 1100412600; RESERVOIR: UPN: 720182-01 / LOT: 1100412600
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male