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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 Premature Elective Replacement Indicator (1483); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Scar Tissue (2060)
Event Date 07/13/2016
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 healthcare provider (hcp) regarding a patient receiving bupivacaine [12 mg/ml] at a rate of 0. 071 mg/day, and morphine [50 mg/ml] at a rate of 0. 297 mg/day via intrathecal drug delivery pump for non-malignant pain and complex regional pain syndrome type i. It was reported that there was a pump alarm. The pump should have reached end of service (eos) near the end of march, so based on longevity the pump should be alarming. The patient reported pain as a 10 out of 10 on the pain scale. It was reported that the patient always comes in at a 10 out of 10 on the pain scale which makes it difficult to determine when/if the therapy effectiveness has ever changed. There were also volume discrepancies noted on (b)(6) 2016 (expected reservoir volume: 9. 3 ml; actual reservoir volume: 7 ml) and (b)(6) 2016 (expected: 6 ml; actual: 2 ml). The hcp performed a dye study on (b)(6) 2016. The dye study showed problems with the pump flow. The implanting doctor then ordered that the patient be weaned off the drug and go through another trial before they consider replacing the pump. The patient was weaned down off the drug starting last summer. The patient stated that they felt better after the test dose on (b)(6) 2016. A ct milogram back on (b)(6) 2016 and were not sure why this was performed but believes the doctor wanted this performed as a routine check prior to replacing the pump. There were no further complications reported/anticipated.
 
Manufacturer Narrative
The event is now considered a serious injury. Recall and notification are no longer applicable. Correction number z-1570-2014 no longer applies.
 
Event Description
Additional information was received from a manufacturer representative on (b)(6) 2017. The pump was being replaced on (b)(6) 2017 and possibly the catheter as well. The drug would not be placed in the new pump until the patient went to the clinic post surgery. They removed a portion of the catheter and cerebrospinal fluid (csf) was seen. The sutureless connector piece was encased in scar tissue so it was hard to measure. There were no further complications reported or anticipated.
 
Event Description
Additional information was received. On (b)(6) 2016, the patient saw the surgeon for evaluation before replacing the pump system. This had been put into place due to the pump elective replacement indicator (eri) less than 10 months physician ordered routine study (ineligible). Multiple attempts were made in regards to getting the patient scheduled but the patient failed to follow through. The patient did not get a dye study for 3 months and at that time it was determined to have abnormal flow. The alarm and volume discrepancies were resolved.
 
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
Additional information was received. It was reported that the notes that were read were that her pump was eos and the managing physician knew that it was eos. The physician wanted to let her pump run dry and get to eos so he could evaluate how bad her pain is and what therapy she needed to depend on. The patient and physician decided that she needed the pump. During the case the physician disconnected her old catheter. There was no back flow at the cap site. She also had a mass of tissue encapsulating an unknown length of catheter. He cut above the fat and when he did she had backflow of csf. He decided to connect another catheter piece to the catheter and replaced with a new pump. There was so much catheter tangled in the mass of fat. The physician tried to dissect as much as he could to try and get a known catheter length, but unfortunately he couldn't so her pump is set to "no known cath length".
 
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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 Key6527143
MDR Text Key102761649
Report Number3004209178-2017-09214
Device Sequence Number1
Product Code LKK
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,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2010
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 Received06/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
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