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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICE CREEK MANUFACTURING SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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RICE CREEK MANUFACTURING SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8627L18
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Cerebrospinal Fluid Leakage (1772); Chest Pain (1776); Dyspnea (1816); Edema (1820); Headache, Lumbar Puncture (2186); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Continuation of concomitant products: product id: 8709, lot# j0177964r, implanted: (b)(6) 2001, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump for non-malignant pain / other non-malignant pain. It was reported that the patient had her pump removed and however still had the ¿leads¿ (catheter) implanted. Magnetic resonance imaging (mri) information for abandoned catheters was reviewed at the time of the report. The mri procedure was not due to a problem with the patient¿s device or therapy. No patient symptoms were reported regarding the mri. It was indicated that the patient told the hcp that their pump was removed because it was not working correctly for the patient and she wanted to go backto taking oral medication. No out of box failure was reported. It was indicated that the patient had no symptoms. Regarding if there was a sudden or gradual change in therapy/symptoms, not applicable was noted. The date of the event was unknown. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Update: the previously applied patient code (b)(4) is no longer applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a healthcare provider (hcp). Regarding the pump having been removed because it was not working correctly for the patient, it was clarified that it was not working well, and the patient was having side effects and experienced edema of their lower extremity (le), shortness of breath (sob), and chest discomfort with sudden onset. It was further indicated that there was a gradual occurrence over the year before explant and there was concern / question if it was flipping; almost not getting medication then all the sudden a release of medication. The patient had no side effect from pump removal; however, the patient had a spinal leak and headache. They had a repeat surgery to repair the leak. The cause of the pump not working correctly for the patient was indicated as having been unknown. Regarding the initial report of the catheter having been left implanted, it was clarified that the catheter was removed on (b)(6) 2004. The cause of the catheter having been left implanted was further indicated as being not-applicable (was explanted). The patient¿s weight at the time of the event was unknown. Regarding the current status of the explanted devices it was noted as having been explanted in 2004 and they did not have the device. The patient's weight at the time of the event was unknown.
 
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Brand NameSYNCHROMED EL
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
RICE CREEK MANUFACTURING
700 central avenue ne
minneapolis MN 55432
Manufacturer (Section G)
RICE CREEK MANUFACTURING
700 central avenue ne
minneapolis MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7713573
MDR Text Key114817476
Report Number6000030-2018-00059
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2002
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

Patient Treatment Data
Date Received: 07/24/2018 Patient Sequence Number: 1
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