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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 No Audible Alarm (1019); Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient who was receiving an baclofen with concentration 2000 mcg/ml at a dose rate of 132. 1 mcg/day via an implantable pump for intractable spasticity and multiple sclerosis. It was reported that the patient recently had magnetic resonance imaging (mri) performed. The mri was not due to a suspected problem with the patient¿s device or therapy. A motor stall was seen at initial interrogation. Regarding the pump logs, the motor stall recovery message had not occurred. It was noted as having been 3+ hours since the patient had exited the mri field, but the pump had not been read post mri until about 15 minutes prior to the report (the date and time of the call report was (b)(6) 2018 03:27 pm). Reviewing telemetry state and re-interrogation the pump with logs was being considered. Interrogation did not result in a motor stall recovery as the pump was programmed in a minimum rate mode. The company representative planned to wait another 20 minutes and continue to re-interrogate for a new set of event logs until the motor stall recovery message could be confirmed. Neither the patient nor the physician had heard the audible pump alarm. No medical symptom was reported. A sudden or gradual changed in therapy or symptoms was noted as being not applicable. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the company representative april 10, 2018. Regarding actions and interventions taken, technical services had been called. No further information was available at the time. The representative was waiting to hear back from the physician. The patient's weight was unknown, and would not be available.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the company representative april 26, 2018. The rep reported that no other actions were taken other than calling technical services. The rep stated that the alarm could not be heard and the motor stall had recovered. No additional information was available.
 
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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 Key7408507
MDR Text Key105250473
Report Number3004209178-2018-06784
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2013
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 Received04/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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