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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7483583
MDR Text Key107243942
Report Number3004209178-2018-09997
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 05/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/19/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/03/2018 Patient Sequence Number: 1
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