MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS Pump; prosthesis, penis, inflatable

Model Number	72404233-12
Medical Device Problem Codes	Signal Artifact/Noise (1036); Nonstandard Device (1420); Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Perforation (2001); Impaired Healing (2378); Numbness (2415); Localized Skin Lesion (4542); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is being requested of a local representative for the model and serial number of the lead.This report will be updated once this information is obtained.
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited noise.Device data was sent to rhythmcare for review.Data review determined there was oversensing and undersensing of the reported noise.Rhythmcare then provided further troubleshooting options to be considered at the next follow up appointment.This lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that, during an inflatable penile prosthesis (ipp) implant procedure, a rupture occurred at the corpora cavernosa after device placement.The rupture was located at the site of a penile plaque that had previously undergone four cycles of xiaflex injection and penile modeling.As a result, a surgical intervention was required to repair the rupture before completing the procedure, in which an additional incision was made over the rupture site to allow for grafting and tissue repair.Following the surgery, the patient experienced an extended healing period, during which he reported soreness at the repair site, along with concerns about foreskin swelling, tightness, and numbness.He also described a thickened area behind the glans, scrotal pain, pain at the scrotal incision site, and increased sensitivity in that area.Several days later, the patient noted a knobbly ridge on the right side of the device when inflated, describing it as similar to a seam.The ridge was not uncomfortable but was noticeable upon palpation.No additional patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem correction to field c2/d10: concomitant product/therapy (1) model number/catalog number: 720185-01 serial number: n/a batch/lot number: unknown model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4) detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specification.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of healing impaired, pain, perforation, swelling, numbness, nerve damage, localized skin lesion, perforation, and device operates differently than expected was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS 700 CX MS Pump
• Common Device Name: prosthesis, penis, inflatable
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• 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 ; +1(651)582-6168
• MDR Report Key: 25699800
• Report Number: 2124215-2026-35645
• Device Sequence Number: 9443810
• Product Code: JCW
• UDI-Device Identifier: 00878953009797
• UDI-Public: (01)00878953009797(17)260910(10)1100586324
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2026

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: 09/10/2026
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1100586324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 08/07/2026; 08/03/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/11/2026; 08/31/2026
• Date Device Manufactured: 09/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male