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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 Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Loss of Range of Motion (2032); Visual Disturbances (2140); Weakness (2145); Tingling (2171); Dysphasia (2195); Myalgia (2238); Therapeutic Response, Decreased (2271); Anxiety (2328); Arthralgia (2355); Numbness (2415); Ambulation Difficulties (2544)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient who was receiving an lioresal with concentration 2000 mcg/ml at a dose rate of 236 mcg/day via an implantable pump for intractable spasticity and myelopathy. It was reported that the patient visited the emergency room today. The patient was experiencing withdrawal symptoms. The pump was checked with the tablet and there were no alerts (only information) showed up. The logs were checked and there were no issues found. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product id 8596, serial# (b)(4), implanted: (b)(6) 2006, product type: catheter. Udi# (b)(4). Product id 8596sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter, udi# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a company representative. The hcp was unable to aspirate the catheter during a dye study on (b)(6)2019. The hcp tried several times to aspirate. No interventions were taken. It was unknown if the issue was resolved. Patient status at time of this report was alive - no injury.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated further troubleshooting/diagnostics were not performed at this time. However, the physician reported that the patient would be set up for a dye study and a date for the dye study has not been provided. The cause of the withdrawal symptoms was unknown. It was noted the hcp was given the information and what clinical actions she may have taken outside of the manufacturer¿s assistance was unknown. It was also unknown if the withdrawal symptoms have been resolved and device remained implanted. The patient¿s weight was also unknown. No further complications were reported or anticipated.
 
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) via a company representative (rep) indicated the physician tried many times to aspirate catheter during the dye study on (b)(6) 2019. The cause was not determined. It was noted it had not been resolved to their knowledge. Patient reported she was receiving good relief and the pump remained implanted. No further complications were reported or 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 Key8520598
MDR Text Key142185212
Report Number3004209178-2019-07577
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2014
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 Received05/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/24/2012
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: 04/16/2019 Patient Sequence Number: 1
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