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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 Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/01/2017
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 patient who was receiving baclofen (unknown) at a concentration of "the highest concentration; 1100 mg, a little over 1100" at an unknown dose via intrathecal drug delivery pump for intractable spasticity and multiple sclerosis.It was reported that the patient's doctor told her that he thought the battery in the pump was depleting before it was supposed to.The patient reported a gradual, major return of symptoms that started "sometime in (b)(6) 2017" patient services redirected the patient to the doctor regarding the return of symptoms.No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information received made this event non-reportable.No further regulatory reports will be submitted unless the information is received making the event reportable.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp).It was reported that there was no problems with the pump and the patient was being scheduled from normal revision.No further complications were reported as a result of this event.Additional information was received from a consumer via a representative.It was reported that the patient needs to have their pump replaced.It was noted that the patient had 100 mg/day of baclofen injected via her pump and it had slowed down.It was unknown if a pump was alarming.Information on financial assistance for a patient without insurance was requested.No further complications have been reported as a result of this event.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key7209561
MDR Text Key98166919
Report Number3004209178-2018-01099
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 Other
Type of Report Initial,Followup,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2018
Initial Date FDA Received01/22/2018
Supplement Dates Manufacturer Received01/22/2018
01/22/2018
Supplement Dates FDA Received01/22/2018
01/26/2018
Date Device Manufactured04/05/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age41 YR
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