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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Overdose (1988); Complaint, Ill-Defined (2331)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

Please refer to regulatory report # 3007566237-2018-00910 for the reference of the unidentified pump issue with the previous pump.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign health care provider (hcp) via a manufacturer representative regarding a patient who received an unknown drug in an implantable pump for an unknown indication for use.It was reported an overdose experience/symptoms occurred after replacement.No further information was provided.Additional information was received.It was reported the pump was implanted on (b)(6) 2018 , and the event occurred on the same date.Prior to the pump replacement, there was concern regarding a possible unidentified fault in the pump system, as spasm control had been lost.It was stated the previous pump had been set to a dose of 900 mcg/day.Following implant of the new pump, they were concerned that if the unidentified problem had been corrected, then the previous dose of 900 mcg/day could result in overdose.The new pump was set to a reduced dose of 500 mcg/day, with arrangements to monitor the patient in the high dependency unit (hdu).The concentration of baclofen used was 3000 mcg/ml.At approximately 02:00, the patient's vital signs began to raise concern, and overdose symptoms began to emerge.The patient became hypotensive with systolic blood pressure less than 80, they were increasingly drowsy but arousable, and their lower limbs became totally flaccid to passive movement.Troubleshooting included the monitoring system which was set up prior to the incident occurring so that the emerging overdose situation was quickly spotted.The pump was switched to minimum rate for a period of approximately 5 hours.During this period, the lower limb muscle tone began to increase, blood pressure returned to the previous level, and the patient became wakeful.The infusion was then recommenced at a further reduced rate of 200 mcg/day.Pump logs were not available.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

The name of the initial reporter and facility involved in the event were provided.

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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7379887
• MDR Text Key: 103775365
• Report Number: 3007566237-2018-00911
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Date Device Manufactured: 08/14/2017
• 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): Other
• Patient Age: 22 YR