MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX? TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404453
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).The event date 05/13/2025 was used as an estimate, based on the reported onset occurring within 2 weeks ago.
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis ipp experienced significant post operative dissatisfaction, referring to it as the most negative surgical experience to date.The patient reported being unable to fully inflate the cylinders, experiencing ongoing soreness and discomfort at the incision site, and achieving only partial inflation.The pump was described as extremely stiff, raising concerns about a possible sticky valve.Additionally, the physician noted during a prior visit that the pump appeared to be positioned higher and to the left within the scrotum.The patient mentioned that attempts to inflate the device in warm water provided some relief.A follow up appointment is scheduled for further physician evaluation.No additional information was provided.
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis ipp experienced significant post operative dissatisfaction, referring to it as the most negative surgical experience to date.The patient reported being unable to fully inflate the cylinders, experiencing ongoing pain and discomfort at the incision site, and achieving only partial inflation.The pump was described as extremely stiff and noted during a prior visit that the pump appeared to be positioned high and to the left within the scrotum.The patient mentioned that attempts to inflate the device in warm water provided some relief.Additional information stated that during physician follow up appointment topical lidocaine was provided for pain, and a second opinion was recommended.No additional interventions were noted, and revision surgery had not been confirmed.No additional information was provided.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).The event date 05/13/2025 was used as an estimate, based on the reported onset occurring within 2 weeks ago.
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis (ipp) experienced significant post-operative dissatisfaction, referring to it as the most negative surgical experience to date.The patient reported being unable to fully inflate the cylinders, experiencing ongoing pain and discomfort at the incision site, and achieving only partial inflation.The pump was described as extremely stiff and noted during a prior visit that the pump appeared to be positioned high and to the left within the scrotum.The patient mentioned that attempts to inflate the device in warm water provided some relief.Additional information stated that during physician follow up appointment topical lidocaine was provided for pain, and a second opinion was recommended.No additional interventions were noted, and revision surgery had not been confirmed.No additional information was provided.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).The event date 05/13/2025 was used as an estimate, based on the reported onset occurring within 2 weeks ago.Correction to field b5: describe event or problem.Correction to field h6: device codes.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Review of the dhr confirmed the device met specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).The event date 05/13/2025 was used as an estimate, based on the reported onset occurring within 2 weeks ago.Correction to field h7: if remedial act init, type correction to field h9: correction/removal reporting number.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Review of the device history record (dhr) confirmed the device met specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis (ipp) experienced significant post operative dissatisfaction, referring to it as the most negative surgical experience to date.The patient reported being unable to fully inflate the cylinders, experiencing ongoing pain and discomfort at the incision site, and achieving only partial inflation.The pump was described as extremely stiff and noted during a prior visit that the pump appeared to be positioned high and to the left within the scrotum.The patient mentioned that attempts to inflate the device in warm water provided some relief.Additional information stated that during physician follow up appointment topical lidocaine was provided for pain, and a second opinion was recommended.No additional interventions were noted, and revision surgery had not been confirmed.No additional information was provided.

• Brand Name: AMS 700 LGX? TENACIO? 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: 22324481
• Report Number: 2124215-2025-40248
• Device Sequence Number: 15656426
• Product Code: JCW
• UDI-Device Identifier: 00191506021443
• UDI-Public: (01)00191506021443(17)261021(10)1100615807
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404453
• Device Catalogue Number: 72404453
• Device Lot Number: 1100615807
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 08/13/2025; 01/20/2026; 03/24/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/10/2025; 02/10/2026; 09/25/2026
• Date Device Manufactured: 10/21/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0144-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 72018501, LOT 1100642163.; RESERVOIR UPN 72018501, LOT 1100642163.; RESERVOIR UPN 72018501, LOT 1100642163.; RESERVOIR UPN 72018501, LOT 1100642163.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male