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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2016
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 company representative regarding a patient receiving an unknown medication via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2018 it was reported that the patient was in the office for a normal refill. Interrogation showed 2 ml should be in the reservoir; however, 16 ml was aspirated. The patient did not report any withdrawal symptoms. There were no known environmental, external, or patient factors that may have led or contributed to the issue. The physician programmed the pump to minimum rate and was planning to bring the patient back to the office at their next appointment on an unknown date. It was unknown if the issue was resolved at the time of the report. No surgical intervention had occurred, and it was unknown if surgical intervention was planned for the future at the time of the report. The patient status was reported as ¿alive ¿ no injury¿. It was noted that the hcp had no further information regarding the event. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer via the food and drug administration (fda) on (b)(6) 2018. It was reported that the pump was implanted on (b)(6) 2014, and was refilled every 90 days or so. Problems were reportedly indicated by the amount of morphine left in the pump when it was time for refill. It was adjusted numerous times, but pain in the back was unabated. Break-through pain meds were administered in the form of oxycodone (15mg), which were the pain meds the patient was trying to get off of and led to the pump implantation. As recent as last week (relative to (b)(6) 2018), the problem was again identified and a procedure was to be scheduled to infuse contrast dye into the pump and "leads" to determine whether there was a kink in the catheter or a leak from the pump. It was discovered that the pump was under recall, and the consumer had never been informed of any recall. The consumer reportedly felt that this was a severe issue which could be life threatening. Concomitant medications included zetia, neurontin, clopidogrel bisulfate, metoprolol tartrate, trazodone, ancept, benazepril, seroquel, namenda, and rapatha. It was indicated that the event was life threatening and required intervention.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the company representative went to the hospital to interrogate the pump prior to explant. The patient and their spouse expressed dissatisfaction with the pump. They stated it ¿never worked right¿. The spouse read on-line that the pump had been "recalled" and they blame a problem with the pump for not working. They also stated they felt the physician didn't work with the pump correctly. Apparently the patient didn't want to use the pump anymore, and the physician programmed the pump to minimum rate and the patient wasn¿t seeing that physician anymore. The pump was used to deliver dilaudid 20mg/ml at minimum rate. It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue or if any diagnostics or troubleshooting had been performed. The actions and interventions taken to resolve the issue was the patient decided to have the pump/catheter explanted. The issue was resolved at the time of the report and it was indicated that the physician would not have any further information regarding the event. The patient status was noted as alive, no injury and no further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type catheter. Other relevant device(s) are : product id: 8780, serial# (b)(4), ubd 2015-09-11 udi# (b)(4). Analysis of the pump revealed no anomaly. Analysis of the catheter revealed catheter body damage to transition tube. If 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
MDR Report Key7544107
MDR Text Key109237150
Report Number3004209178-2018-11862
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/25/2018 Patient Sequence Number: 1
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