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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404251
Device Problem Defective Device (2588)
Patient Problems Scarring (2061); No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced the ams 700 inflatable penile prosthesis pump to have an activation problem and needs the pump to be changed.A revision surgery has been scheduled.No patient complications were reported in relation to his event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.
 
Manufacturer Narrative
Analysis of the lgx preconnect ms 15cm ps iz revealed that the pump failed to inflate and deflate.The ams 700 reservoir was visually inspected and functionally tested.The reservoir performed within specifications.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.Additional information received that the revision surgery occurred on (b)(6) 2019.The preconnect pump and reservoir were placed due to a technical problem with the scrotal pump.Additional information received that the patient was dissatisfied and there were technical problems with the pump.There were no technical problems that could be found but the pump still did not work correctly.Through operation, a minor scar formation around the reservoir was detected.The reservoir and pump were changed.System components reservoir model- 72404155 lot sn- (b)(4) mfg date- 08/10/2015 exp date- 07/25/2017 gtin- 00878953003207.
 
Event Description
It was reported that the patient experienced the ams 700 inflatable penile prosthesis pump to have an activation problem and needs the pump to be changed.A revision surgery has been scheduled.No patient complications were reported in relation to his event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.
 
Manufacturer Narrative
Additional information received that the revision surgery occurred on (b)(6) 2019.The preconnect pump and reservoir were placed due to a technical problem with the scrotal pump.Additional information received that the patient was dissatisfied and there were technical problems with the pump.There were no technical problems that could be found but the pump still did not work correctly.Through operation, a minor scar formation around the reservoir was detected.The reservoir and pump were changed.System components reservoir model- 72404155, lot sn- (b)(6), mfg date- 08/10/2015, exp date- 07/25/2017, gtin- 00878953003207.
 
Event Description
It was reported that the patient experienced the ams 700 inflatable penile prosthesis pump to have an activation problem and needs the pump to be changed.A revision surgery has been scheduled.No patient complications were reported in relation to his event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.
 
Manufacturer Narrative
Additional information received that the revision surgery occurred on (b)(6) 2019.The preconnect pump and reservoir were placed due to a technical problem with the scrotal pump.
 
Event Description
It was reported that the patient experienced the ams 700 inflatable penile prosthesis pump to have an activation problem and needs the pump to be changed.A revision surgery has been scheduled.No patient complications were reported in relation to his event.Further information was requested and is not yet available.Should additional information become available, this complaint will be reassessed.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8360454
MDR Text Key136841635
Report Number2183959-2019-61023
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/08/2018
Device Model Number72404251
Device Catalogue Number72404251
Device Lot Number0125000004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Date Manufacturer Received06/03/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age73 YR
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