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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 Excess Flow or Over-Infusion (1311); Decrease in Pressure (1490); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Overdose (1988); Vomiting (2144); Loss of consciousness (2418)
Event Date 09/03/2018
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) via a device manufacturer representative regarding a patient receiving lioresal (2000 mcg/ml at 454. 7 mcg/day) via an implantable infusion pump. The indication for use was intractable spasticity and head/brain injury. It was reported that the patient had been flying and after landing had emesis, then passed out. The caller stated that the patient was admitted to the hospital and was intubated around 0642 on (b)(6) 2018. Per the caller the patient was extubated at 1700 that night. The physician at the er requested a device manufacturer representative be sent to the hospital to interrogate the pump; he inquired whether the patient being in a higher altitude could have affected the pump. It was reported that the pump logs were checked and the pump was confirmed to be working properly. At the time of this report the patient was noted to be awake and alert. 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 healthcare provider (hcp) indicated that the patient was in colorado residing in altitudes near 8 ,000 feet. The hcp stated that she had no idea that altitudes had an effect on dosing. The hcp was faxed on-label information for altitude compatibility with the pump. 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 indicated that the patient had the pump filled while in colorado and that the pump malfunctioned effected the patient's breathing, giving him too much medication and overdosing him. It was reported that the patient spent 3 days in the intensive care unit. It was noted that the healthcare provider wanted the patient to come into the office but that they were trying to locate a closer hcp. No further complications have been 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 Key7846694
MDR Text Key119239906
Report Number3004209178-2018-19908
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Type of Report Initial,Followup,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2013
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: 09/05/2018 Patient Sequence Number: 1
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