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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 8637-20
Device Problems Pumping Stopped (1503); Battery Problem (2885); Insufficient Information (3190)
Patient Problems Diarrhea (1811); Headache (1880); Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving dilaudid at an unknown dose and concentration via an implantable infusion pump for non-malignant pain. It was reported that the patient's pump had alarmed. The patient reported that it was a critical alarm. The patient was due for a refill on (b)(6) 2019. The patient had their drug increased on (b)(6) 2019 because they were having issues with pain. A manufacturer's representative (rep) could "see" that the pump "had died," from 9am-130pm on (b)(6) 2019. The rep "rebooted," the pump. The patient reported the pump alarm started going off again the night of 019. The patient would be getting the pump replaced on (b)(6) 2019. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported the cause of the motor stall was unknown. The pump was replaced on (b)(6) 2019. The patient weight was (b)(6). No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer via a device manufacturer representative indicated that the patient was receiving dilaudid (20 mg/ml at 8 mg/day) via an implantable infusion pump. It was reported that the patient experienced withdrawal symptoms of nausea, diarrhea and headache due to premature battery depletion. It was noted that the elective replacement indicator was (b)(6) 2020 (14 months). It was unknown if any environmental/external/patient factors that may have led or contributed to the issue. The pump was replaced and the issue was reported to be resolved. It was noted that the patient was alive with no injury. The explanted device was in the possession of the hospital. No further complications have been reported as a result of this event.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key8780817
MDR Text Key150711197
Report Number3004209178-2019-13301
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2014
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/19/2013
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: 07/11/2019 Patient Sequence Number: 1
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