MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); Underdose (2542)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial# unknown, implanted: unknown, explanted: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown, (b)(4).(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative and the patient's family member regarding a patient who was receiving baclofen 3,000 mcg/ml at 833.9 mcg/day via an implantable pump for an unknown indication for use.It was reported that there was a suspected underdose.The patient was admitted to the hospital at 3am on (b)(6) 2018 as they were having seizures and further information reported that it was an extended seizure.The patient was admitted to the critical care unit at 4am.It was reported that someone from medtronic and the patient's pain management physician came to the hospital after the patient had the seizure and checked the implants.It was reported that the patient was sedated and the pump was interrogated by the physician.It was reported that no alarms were apparent; it was confirmed that the implants were working.It was reported that the physicians were inquiring about an magnetic resonance imaging (mr)i to determine the cause of the seizures.It was reported from the patient's family member reported that the potential mri was not due to a problem with the medtronic device or therapy and that the seizures were not related to the medtronic device or therapy.The physicians were suspecting the infusion system for the seizures.It was noted that they did not conclude whether the patient was in potential overdose or underdose.It was reported that the estimated reservoir volume was 15.3 ml.The pump was emptied and an actual volume of 15ml was aspirated.Since there were no alarms on the logs, the pump was deemed to be functioning properly.A review of the provided pump logs did not identify any anomalies.The pump was refilled with 20ml of baclofen and no change to the daily dose was prescribed.It was reported that the issue was resolved at the time of this report.It was reported that no surgical intervention had occurred and no surgical intervention was planned.The patient status at the time of this report was unknown.It was reported that the patient's pervious pump was replaced due to normal battery depletion on 2013 outside the united states.Additional information was received that reported that the patient was an inpatient on medical ward and that they were awaiting results of all investigations.It was reported that the diagnosis remains unclear, but it is possible that seizures were drug toxicity-related.It was further reported from the physician that there was no evidence of a pump malfunction or baclofen overdose.The comment from the physician was that "i cannot exclude underdose of baclofen due to a catheter problem".No further complications were reported and/or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7483583
• MDR Text Key: 107243942
• Report Number: 3004209178-2018-09997
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/03/2018
• Date Device Manufactured: 01/19/2012
• 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): Hospitalization; Life Threatening
• Patient Age: 46 YR