• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • 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
 

MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Aspiration Issue (2883)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving compounded baclofen, 2000 mcg/ml concentration at 1200 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and other spasticity. It was reported that lack of therapy despite increases in dosages, as well as residual volumes higher than expected at refill occurred. Any environmental/external/patient factors were unknown. Dye study was attempted on 3/27, but was unable to aspirate catheter. The hcp was unable to determine exact cause of sluggish cerebrospinal fluid (csf) flow through the catheter during interoperative troubleshooting. The hcp replaced the catheter after attempts to troubleshoot and diagnose the existing catheter's lack of patency failed to identify the exact issue. The hcp did find a significant amount of tissue that had accumulated in the sutureless connector portion of the catheter. The hcp also replaced the pump prophylactically as it was nearly 5 years old. The pump segment of the catheter, the pump, and the tissue removed from sutureless connector would be returned to the manufacturer for analysis on the sutureless connector/pump connection. At the time of this report, the issue was resolved and patient status was alive-no injury. No further complications were reported.
 
Manufacturer Narrative
The pump and catheter were returned, and analysis found pump/miscellaneous/overinfusion- undetermined root cause and catheter/catheter body/damage to transition tube. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7413133
MDR Text Key104920552
Report Number3004209178-2018-06930
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
-
-