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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 Premature Elective Replacement Indicator (1483); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2017
Event Type  malfunction  
Event Description
Information was received from a consumer regarding a patient receiving intrathecal baclofen 2000 mcg/ml at an unknown dose via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient had the pump refilled and went in every 6 weeks for a refill.During the pump refill on (b)(6) 2017, the telemetry printout stated that elective replacement indicator (eri) had occurred on (b)(6) 2017 and end of service (eos) would occur on (b)(6) 2017.The consumer¿s question was based on a reply by the healthcare provider (hcp) that the pump would slow down and not deliver quite as much but keep working.The consumer felt that ¿based on his electrical background, there was something else occurring that was not linear based.¿ the consumer wanted to understand it further and intervene quickly to prevent any pump failure before the pump was replaced.The consumer knew the patient was at a fairly high dosage rate but did not feel the estimated eri should have dropped this much in 6 weeks.At the patient¿s refill 6 weeks ago (from (b)(6) 2017), the printout stated the estimated eri was 13 months.The consumer was going to follow up with the hcp.The consumer know wanted to know if the patient went back in 2 or 4 weeks from now, would ¿it¿ say that things were worse.There were no medical symptoms reported.No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6406981
MDR Text Key70085264
Report Number3004209178-2017-05654
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 Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2012
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 03/13/2017
Initial Date FDA Received03/15/2017
Supplement Dates Manufacturer Received03/13/2017
Supplement Dates FDA Received10/02/2017
Date Device Manufactured02/25/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011
Patient Sequence Number1
Patient Age24 YR
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