MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

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

Patient Problems Erythema (1840); Fever (1858); Low Blood Pressure/ Hypotension (1914); Staphylococcus Aureus (2058); Sepsis (2067); Complaint, Ill-Defined (2331); Alteration In Body Temperature (2682)

Event Date 08/01/2010

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 regarding a patient receiving clonidine with an unknown concentration for a total dose of 0.5225 mcg/day, bupivacaine with an unknown concentration for a total dose of 9 mg/day, and dilaudid (hydromorphone) with an unknown concentration for a total dose of 4 mg/day via an implantable pump for lumbar radiculopathy.It was reported the patient had two previous manufacturer pumps, but they have been removed and now have a non manufacturer pump.The patient reported with the first pump they got mrsa about 30 days after implant, and it was red.It was stated that the patient just about died.The patient stated that their blood pressure tanked, was burning up and had a temperature of 103 degrees, was septic, and was put on medication through a pic line.It was noted that the patient had to have the pump removed.Event date was noted as (b)(6) 2010.It was noted that the patient no longer has a manufacturer pump, and the situation was resolved.No further complications were reported/anticipated.***there was additional information reported that was not relevant to this event and therefore was omitted;.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6549128
• MDR Text Key: 74553387
• Report Number: 3007566237-2017-01755
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Date Device Manufactured: 05/06/2010
• 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): Life Threatening; Required Intervention
• Patient Age: 48 YR