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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 Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2017
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¿s representative (rep) regarding a drug infusion device. The drugs being delivered were 400 mcg/ml fentanyl at 46. 64 mcg/day and 30 mg/ml morphine (unknown) at 3. 498 mg/day. The reason for use was non-malignant pain and radiculopathy. It was reported that there was an empty pump alarm occurring. The rep had access to the patient and an 8840 clinician programmer. The patient missed a refill. The caller stated that the patient was not able to get the pump filled due to an insurance issue. The patient had been getting filled by pentec, and the patient relocated and found a physician to manage their care and pump moving forward. The hcp would like the alarms silenced. The pump alarms were silenced, the pump was updated to a full reservoir at minimum rate. The event date was listed as (b)(6) 2017. The patient was going to be referred to a surgeon for a pump replacement. There were no symptoms reported. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Additional information indicated that the patient was referred to a surgeon for explant as the device was near end of life. The event is no longer reportable for serious injury, it is reportable for device malfunction. Included 'adverse event <(>&<)> product problem' updated to 'product problem'. 'intervention required' no longer applies. 'serious injury' updated to 'malfunction'. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep on 2018-apr-30. It was reported that the pump alarms were ordered off per the physician. The patient is being referred for pump replacement, as the pump is near end of life. The managing physician information was provided. There were no further complications reported/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 Key7472062
MDR Text Key106855571
Report Number3004209178-2018-09560
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
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received04/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/31/2012
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: 04/30/2018 Patient Sequence Number: 1
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