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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 Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Intermittent Infusion (2341); Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was receiving fentanyl 50 mcg/ml; 35 mcg, baclofen (unknown) 50 mcg/ml; 35 mcg and dilaudid 15 mg/ml; 10. 5mg via an implantable pump. Indication for use was spinal pain. The date of the event was (b)(6) 2017. It was reported the pump started to alarm around the house "probably a week". The pump had been in for four years. The patient kept hearing an alarm in their house but did not think it was their pump. The patient had a blanket around them and did not believe it was the pump that was alarming. The patient went to the hcp "it's been probably a week" and had been there since then for a refill. The patient was ¿in extreme pain¿ that started since wednesday, which was believed to be the (b)(6) and was the day the patient went in. A five percent increase was done. The patient was to follow up with the healthcare provider. There was an error that showed up; a motor stall. Per the pump print out it started at 16:24. There were several different dates. There were several motor stalls that show up between (b)(6) 2017. End of service (eos) occurred prematurely on (b)(6) 2016 with the original date of (b)(6) 2017 for the eos when previously interrogated. The elective replacement indicator date was unknown because the event logs had numerous stalls and recoveries that took up space. There were 15 numerous motor stalls and recoveries beginning on the date of (b)(6) 2017 for the first stall per the event logs. There were six stalls that occurred on (b)(6) 2017 with seven recoveries. The pump was replaced (b)(6) 2017. No further complications were reported/anticipated.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Eval code - conclusion code ¿ is being updated for this event. The device codes were updated. Patient code (b)(4) also applies.
 
Event Description
Additional information was received from the company representative (rep) via the return paperwork and the pump logs were provided last examined (b)(6) 2017 (last changed (b)(6) 2017). The logs showed eos occurred on (b)(6) 2017. A terminal event had occurred in the pump. A stopped pump period may exceed tube set message was seen on (b)(6) 2017 and the multiple motor stalls were confirmed starting on (b)(6) 2017. The elective replacement indicator (eri) also occurred and ¿schedule to replace the pump by (b)(6) 2017¿ was seen in the logs. The eri date was not in the logs. It was noted there was early eri, early eos, and multiple motor stalls. There was no patient injury and the patient recovered without sequela. The patient experienced a sudden loss of therapy. A dye study and rotor study were not performed. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
The pump was returned, and analysis found a motor/feedthrough anomaly/shorting across the insulator. Analysis identified electrochem ical migration across the electrical feed-through insulator which caused an electrical short. The electrical short resulted in a {low battery reset/motor stall}. Analysis identified residue in the motor gear train that contributed to the motor stall{s}. Analysis found corrosion and or wear and or lubrication and stall due to shaft bearing. Analysis identified residue on the gear shaft of the motor gear train that resulted in the motor stall(s). The catheter access port (cap) was aspirated and found to be patent. Dispense accuracy testing could not be completed due to reset {300 ul/day}. Dispense accuracy testing could not be completed due to reset {24,000 ul/day}. Visual inspection of the hybrid (circuit board) did not identify any anomalies. Pressure testing did not identify any leaks or breaches in the internal pump tube. (b)(4) no longer applies. (bif information is provided in the future, a supplemental report will be issued.
 
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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 Key6540908
MDR Text Key101186298
Report Number3004209178-2017-09558
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2011
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: 05/03/2017 Patient Sequence Number: 1
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