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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Oversedation (1990); Cognitive Changes (2551); Lethargy (2560)
Event Date 10/31/2017
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 professional (hcp) via manufacturer representative. The cause of patient symptoms was un determined. The hcp believed the patient symptoms had resolved. Surgical intervention has not been scheduled. The provided information has been confirmed with the physician.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that on (b)(6) 2017 the patient presented to the emergency room with lethargy. The pump was interrogated and seemed to be functioning normally with no error messages. The healthcare professional decreased the dose by 30%. It was reported the issue was resolved at the time of the report. At the time of the report the patient was on 90mcg/ml baclofen at 16. 551mcg/day, 20mg/ml morphine at 3. 678mg/day, and 36mg/ml bupivacaine at 6. 620mg/day. The patient's status at the time of the report was noted as "alive-no injury. " no further complications were anticipated/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 that the patient was overly sedated. Narcan was administered twice, 1 mg each time and the patient was still overly sedated so they believed the condition was caused from the patient's pump. The hcp did not have access to a clinician programmer. The patient had not recently been seen by the pump follow-up doctor. The patient was at her primary doctor today for symptoms of being sleepy/lethargy/kind of confused that began two days ago on tuesday. It was discovered today that the patient's blood sugar level was 31-32 (in the 30s), that was addressed/fixed with glucose but the patient was still experiencing issues of over sedation. The patient was currently on po gabapentin and a lot of other meds/2 different meds with some of them being amlodipine, furosemide and another drug. The patient was also overly sedated and admitted 2017 (b)(6) and ended up in the icu. The patient recovered from that.
 
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 manufacturer representative (rep)regarding a patient who was receiving morphine, 20mg/ml concentration at 6. 54 mg/day dose, baclofen, 90 mcg concentration at 29. 53 mcg/day and bupivacaine, 36 mcg/ml concentration at 11. 18 mcg/day dose via intrathecal drug delivery pump for non-malignant pain and failed back syndrome-other. It was reported that the rep got called into the intensive care unit (icu) to turn a pump down. Pump was being managed by advanced pain management and the icu wanted it turned down, patient had episodes of decreased blood pressure. Narcan was given a few times and blood pressure was stabilized. Environmental/external/patient factors that may have led or contribute to the issue were unknown, hospital stated they were dealing with an "apm" patient but had little guidance to go by. The rep decreased pump 20 percent per icu orders. For interventions/actions for this issue, they would send patient back to "apm" upon discharge. At the time of this report, it was unknown if the issue was resolved. No surgical intervention occurred and it was unknown if it was planned. Patient status was reported as alive-no injury. Patient weight and medical history were asked but unknown. No further complications were reported.
 
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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 Key6997645
MDR Text Key102596664
Report Number3004209178-2017-23056
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,Followup,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2012
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 Received12/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/10/2011
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: 11/02/2017 Patient Sequence Number: 1
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