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

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.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, 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 Key: 7755029
• MDR Text Key: 116711791
• Report Number: 6000030-2018-00063
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2004
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR