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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Vomiting (2144); Malaise (2359); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)
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 friend/family member regarding a patient who was receiving 2000 mcg/ml of baclofen at 599. 6 mcg/day via an implantable pump for intractable spasticity. It was reported that the patient's pump was "not functioning well". The consumer reported that the patient would go into a "sleep coma". Sometimes the patient would sleep for a whole 24 hours if allowed, noting that the patient would go to bed at 8pm, sleep through the night, and at 10 am still be sleeping. The patient would sometimes need to be physically woken, though the consumer noted that the patient would "look at you for a few seconds and then go back to sleep". After waking the patient, the consumer would give the patient something to eat and the patient will then go back to sleep. The consumer also noted that the patient would "projective vomit all over", stating that the patient will be really sick in the morning and cannot get up from bed. This sickness would go on for the entire day for 2 days. According to the consumer, the patient was sick in bed throwing up. These issues had been going on for about a year, but the year was not confirmed. The consumer had read online that if the patient is getting too much baclofen at one time, "it could set into a slip coma". The consumer had also read that if the patient does not get enough baclofen, there could be vomiting episodes with sickness. The consumer had voiced their concerns with the patient's healthcare provider (hcp) but the hcp did not seem to suggest anything. The hcp did a dye test and there was nothing wrong with the catheter that the hcp could find. No out of box failures or medical/therapy problems associated with a small components product were reported.  and no further patient complications are anticipated or expected as a result of this event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9505030
MDR Text Key183568300
Report Number3004209178-2019-24261
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2018
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 Received12/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2016
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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