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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 End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp). It was reported that the pump was explanted and would be returned to the manufacturer; the cause of the premature end of service (eos) was unknown at the time of this report and the hcp was awaiting analysis. The pump was surgically replaced on (b)(6)2017, and the premature eos was resolved. The expected elective replacement interval (eri) was 2017-dec. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received, indicating that the device was explanted as a result of this event, and was returned to the manufacturer for analysis. The cause of the premature eos was a faulty battery. The premature eos was resolved. No further complications were reported.
 
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 healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving baclofen (concentration of 2000mcg/ml at a dose of 711. 5 mcg/day) via intrathecal drug delivery pump for intractable spasticity and stroke. It was reported that a pump alarm was heard and confirmed by telemetry. The critical alarm occurred due to end of service (eos) (sr) and estimated replacement indicator (eri) occurred. The eri occurred on (b)(6) 2017 and the eos occurred on (b)(6) 2017. It was reported that the eos was expected to occur on (b)(6) 2017 but instead had prematurely occurred. The patient went to the hospital when they heard the pump critical alarm. The pump logs were checked. Technical services reviewed that the pump had premature eos and reviewed that the pump was included in the population of devices that could potentially be affected by the battery performance field action. The rep reported that they were there to replace the pump on this report date, the rep would review considerations with the healthcare professional. No patient symptoms were reported. No further complications were 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 Key6928602
MDR Text Key103215967
Report Number3004209178-2017-21322
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,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2012
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received02/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/02/2011
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 Treatment Data
Date Received: 10/09/2017 Patient Sequence Number: 1
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