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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 Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer on (b)(6) 2017 regarding the patient's implanted infusion pump containing fentanyl (dose and concentration unknown). The indications for use included non-malignant pain and chronic low back pain. It was reported that the patient underwent magnetic resonance imaging (mri) on (b)(6) 2017. The mri was reportedly performed to check the patient's c-spine and t-spine after a car accident in (b)(6) 2016. The mri was not related to the device or therapy. The patient heard the pump alarm, and her personal therapy manager displayed error code 8476, indicative of a motor stall. The mri took place 15 minutes prior. The patient was to follow-up with a healthcare provider to have the pump interrogated and to verify that the pump started back up as expected. No patient symptoms were reported, and no further complications were reported or expected.
 
Event Description
Additional information was received from a consumer (con) on 2017-apr-18. It was reported that the patient called their healthcare professional (hcp) to make sure the motor stall that was observed on (b)(6) 2017 was resolved. It was reported that the pump reset (recovered) on its own. The motor stall had been resolved.
 
Manufacturer Narrative
Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.
 
Event Description
Additional information was received from the healthcare provider on 2017-jun-05. It was reported that it was unknown what troubleshooting was performed or what actions/interventions were taken regarding the motor stall. The hcp confirmed that the patient informed him of the stall, and telemetry confirmed that the stall occurred on (b)(6) 2017 at 09:00. Recovery occurred on (b)(6) 2017 at 10:28.
 
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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 Key6439105
MDR Text Key101065077
Report Number3004209178-2017-06478
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 consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/26/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0592-2009

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