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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 Fall (1848); Headache (1880); Overdose (1988); Pain (1994); Dizziness (2194); Numbness (2415)
Event Date 08/11/2017
Event Type  Injury  
Event Description
Information was received from a consumer regarding a patient receiving fentanyl 3000mcg/ml for a total dose of 606. 1mcg/day and bupivacaine 15mg/ml for a total dose of 3. 030mg/day via an implantable pump for non-malignant pain. It was reported the patient was having a magnetic resonance imaging (mri) and was related to device/therapy. It was noted that since the patient got bupivacaine added in the pump, four days after the patient started to experience pressure headaches, which increased tremendously and everything was going numb from the low back, waist, and butt. The problems from the headache was from "opium overload" through the u of m. It was noted that they were in the process of turning the drug down. It was noted that it has increased the headaches and the patient's feet and legs go numb. Everything from the low back down occasionally goes numb. It was noted when the patient stepped they could not feel their footing and fell. The patient feel 3 weeks ago around (b)(6) 2017 when from the medication the patient got dizzy and fell and missed their footing. The patient was needing an mri of the shoulder, wrist, and elbow. It was thought that the pain was coming from the shoulder. The patient was to have the mri on thursday (b)(6) 2017. It was unknown if it was a gradual or sudden change in therapy/symptoms. Event date was (b)(6) 2017 (about 4 days after refill on (b)(6) 2017). It was noted that the healthcare professional (hcp) wanted a manufacturer representative (rep) to come every 2 weeks to turn down the pump. It was noted that the patient wanted a rep to read the pump on thursday (b)(6) 2017 after mri, and was reviewed mri facility will have to call to see if a rep was available. No further complications were reported/anticipated.
 
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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 Key6867765
MDR Text Key86241996
Report Number3004209178-2017-19389
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 09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2015
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 Received09/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/15/2014
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: 09/14/2017 Patient Sequence Number: 1
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