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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Overdose (1988); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 01/01/2015
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 consumer regarding a patient who was previously receiving fentanyl, clonidine, bupivacaine, and prialt via an implantable pump for non-malignant pain and chronic low back pain. The drug concentrations of fentanyl, clonidine, bupivacaine, and prialt were unknown. The dose rate of clonidine was 10. 132 mcg/day, the dose rate for bupivacaine was 5. 066 mg/day, and the dose rate of dilaudid was 5. 066 mg/day; the dose rates for fentanyl and prialt were unknown. The patient was currently receiving dilaudid of unknown concentration at an unknown dose rate. It was reported the patient¿s doctor added fentanyl to the pump and the patient didn't know when but they ¿put her up to an 11¿. It was described that the patient was in a zombie world, was slow moving, could hardly breath, and was very unbalanced with walking. It was noted that the hospital knew nothing about the pump. It was indicated that the patient didn¿t know if she had the reaction because they had raised the fentanyl so high. Regarding the reaction to fentanyl / ¿zombie world¿, the event occurred in 2015 (year known only). The fentanyl was then gradually decreased until it was removed by their current doctor. The patient thought they put it down to 2. 6. It was also noted that the fentanyl didn't work at all; but described as being about a year or so ago (day, month and year unknown regarding date of event).
 
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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 Key7615690
MDR Text Key111549522
Report Number3004209178-2018-13791
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received06/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/05/2012
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: 06/19/2018 Patient Sequence Number: 1
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