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

Model Number 8627L18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Fall (1848); Paralysis (1997); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient receiving morphine of an unknown concentration and unknown dose and dilaudid of an unknown concentration and unknown dose via an implantable infusion pump for malignant pain and spine/back pain.It was reported by the patient that she received a manufacturer's id card but has had her pump removed.The patient stated that about 3 years after her implant date of (b)(6) 2002 she woke up paralyzed from the waist down.Patient stated she was feeling sick with vomiting and diarrhea and when she woke the next morning and tried to get out of bed she fell flat on her face.Patient stated that as an intervention she had a total system explant in (b)(6) 2007-2008 after which the doctor told the family and boyfriend that he "ripped the pump system right out of the patient".Patient stated that after the pump was pulled out the patient went through withdrawals and was a maniac and they were treating her like a drug addict.Patient was in a wheel chair for almost a year.Patient states she then went to the mayo clinic and they diagnosed her with advanced multiple sclerosis and told her she would probably never walk again.Patient stated she was able to walk now.The situation was resolved and patient was able to walk and all sickness and withdrawal issues had been resolved.The patient noted she was scheduled to have a stimulation device implanted on (b)(6) 2017.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6362179
• MDR Text Key: 68435138
• Report Number: 6000030-2017-00019
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2003
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• 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 Outcome(s): Required Intervention