Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 CX MS PUMP; PROSTHESIS, PENIS, INFLATABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMERICAN MEDICAL SYSTEMS, INC. AMS 700 CX MS PUMP; PROSTHESIS, PENIS, INFLATABLE Back to Search Results
Model Number 72404232-10
Device Problem Positioning Problem (3009)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/21/2020
Event Type  malfunction  
Event Description
Inflatable penile prosthesis (ipp) placed a few months ago.Patient returns for "activation" but doesn't work as it should (something weird with pump which can happen ¿ usually resolves.Patient returns again and still not working.We decided to take to operating room for revision.But when i deliver the pump, it starts to work again.I literally can't get it to fail (once outside of body) and thus i assume that it is positional related in the scrotum.I move it to a different place and it "works." i'm concerned, and assume, that the pump once all of this heals will "fail again" since i didn't replace.Apparently manufacturer knew about this before it was replaced.Surgeon was informed by company that there is a "pump problem" with this device placed/manufactured within the time frame in which this patient received his initial implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMS 700 CX MS PUMP
Type of Device
PROSTHESIS, PENIS, INFLATABLE
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka MN 55343
MDR Report Key10754678
MDR Text Key213663497
Report Number10754678
Device Sequence Number1
Product Code JCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/22/2020,10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number72404232-10
Device Catalogue Number72404232-10
Device Lot Number1000327393
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2020
Event Location Hospital
Date Report to Manufacturer10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24820 DA
-
-