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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 06/04/2018
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 professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving an unknown concentration of fentanyl at minimum rate via an implantable pump for non-malignant pain and other non-malignant pain. It was reported that a motor stall was seen at the initial interrogation on (b)(6) 2018. The patient had recently had an mri and the motor stall had not occurred. It was noted it had not been less than two hours since leaving the mri field. The pump had been running at minimum rate for about 6 months as they were looking to explant the pump however due to other health concerns they had not been able to explant the pump. No symptoms were reported. No further issues were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving an unknown concentration of fentanyl at minimum rate via an implantable pump for non-malignant pain and other non-malignant pain. It was reported that a motor stall was seen at the initial interrogation on (b)(6) 2018. The patient had recently had an mri and the motor stall had not recovered. It was noted it had not been less than two hours since leaving the mri field. The pump had been running at minimum rate for about 6 months as they were looking to explant the pump however due to other health concerns they had not been able to explant the pump. No symptoms were reported. No further issues were reported or anticipated. Additional information was received from a healthcare professional (hcp). The cause of the motor stall was an mri. The stall recovered at 19:58 spontaneously. No further issues were reported 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 Key7575387
MDR Text Key110338833
Report Number3004209178-2018-12782
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
Report Date 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2014
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 Received06/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/25/2013
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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