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

MAUDE Adverse Event Report: RICE CREEK MFG SYNCHROMED EL 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
 

RICE CREEK MFG SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8627L18
Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Weight Changes (2607)
Event Date 06/03/2003
Event Type  malfunction  
Manufacturer Narrative
Occupation: non-healthcare professional (consumer). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who had been receiving an unknown dose and concentration of dilaudid via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported the patient¿s pump did not work since implant, (b)(6)2003. The patient reported they had not used their pump since 2004 or 2005 and it was turned off because it did not work for the patient. It was indicated this happened in 2004 or 2005. The patient reported they gained 86 pounds from implant to the time the pump was turned off. The patient stated she lost 46 pounds after the pump was turned off. No interventions were mentioned. At the time of the report the patient was inquiring about compatibility guidelines for a magnetic resonance imaging procedure (mri). It was reported the mri procedure was not due to a problem with their pump or therapy (it was unrelated). The patient reported they were experiencing symptoms; however, the symptoms were not related to their device or therapy. It was recommended the patient¿s healthcare provider call for mri information. Physician listings were provided to the patient. No further complications were reported or anticipated.
 
Manufacturer Narrative
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 EL
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
Manufacturer (Section G)
RICE CREEK MFG
7000 central ave ne
fridley MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7755029
MDR Text Key116711791
Report Number6000030-2018-00063
Device Sequence Number1
Product Code LKK
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/15/2004
Device Model Number8627L18
Device Catalogue Number8627L18
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-