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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 High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Muscular Rigidity (1968); Tachycardia (2095); Therapeutic Response, Decreased (2271)
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8711, serial (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2018, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8711, (b)(4), ubd: 04-oct-2008, (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provide (hcp) via a company representative regarding a patient who was receiving gablofen with concentration 2000 mcg/ml at a dose rate of 372 mcg/day via an implantable pump for intractable spasticity and post spinal cord injury. It was reported that the patient started having withdrawal symptoms on (b)(6) 2018. Symptoms included tachycardia, itchiness, ¿low b¿ (low blood pressure), and high blood pressure. The patient was admitted to the hospital on (b)(6) 2018. The event occurred during normal use. The logs were checked and nothing was abnormal. Environmental/external/patient factors that may have led or contributed to the issue was indicated as having been none. The issue was not resolved at the time of the report. The patient was without injury regarding their status at the time of the report. Surgical intervention was planned to occur (b)(6) 2018. As per the manufacturer¿s device registry, the pump and catheter were explanted and replaced on (b)(6) 2018. Other medications (oral, etc. ) the patient was receiving at the time of the event was unable to be obtained. No further patient complications have been reported as a result of this event. The patient¿s medical history included traumatic brain injury.
 
Manufacturer Narrative
The initial reporter's name and contact information provided via the initial report is incorrect. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider via a company representative. The person who initially reported the event to the company representative was clarified as being a registered nurse; first name was provided. The cause of the withdrawal symptoms was not determined. They replaced the system last night with a new catheter and new pump. The withdrawal symptoms, tachycardia, itchiness, high blood pressure, and low blood pressure was resolved. The device was to be returned and was further noted as currently in pathology at the hospital.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) indicated the patient was admitted with intrathecal baclofen (itb) withdrawal symptoms. Oral baclofen was given, but the patient was not responding so the pump management doctor prescribed a 25mcg single bolus dose. The hcp declined having the itb emergency procedures forwarded to them stating they have already done multiple event log checks and dose increases and at this time the patient was becoming stable and their tone was better. The hcp stated they were not suspecting the drug infusion system was malfunctioning. Location of symptoms was noted as other. The event date was changed to (b)(6) 2018. The patient's total dose was 428. 7mcg/day. 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 Key7812735
MDR Text Key118120575
Report Number3004209178-2018-19100
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
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/13/2012
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: 08/24/2018 Patient Sequence Number: 1
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