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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)
Event Date 02/28/2016
Event Type  malfunction  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a manufacturing representative regarding a patient receiving intrathecal baclofen via an implantable infusion pump for intractable spasticity and cerebral palsy. The dose and concentration were unknown. It was reported that as of (b)(6) 2016, the patient had been sick for three days. However, when asked if the date was (b)(6) 2016, the reporter confirmed ¿yes, but he was venturing a guess¿. The patient complained of a stomach ache, and they thought it was the stomach virus. That seemed to get better, but then the patient had congestion. ¿muscle convulsions¿ were noted. Every now and then, the patient ¿winced like in sharp pain¿. The patient was afraid the pump was failing. The patient was currently at home, and [their friend/family member] was hesitant to take the patient out and go to the hospital. The patient¿s pump was checked. There were no active alarms, and there was nothing in the pump logs that would suggest a pump issue. The representative explained to the consumer that there still could have been an issue with the rest of the system, but that the patient would need to be seen by his physician for the pump to look f urther into it. The patient¿s primary care physician was to see the patient on the evening of (b)(6) 2016. No interventions were mentioned. There were no further complications 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 Key6768230
MDR Text Key81852027
Report Number3004209178-2017-16273
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
Report Date 08/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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