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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 Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Analysis of the pump on (b)(6) 2018 revealed no anomaly. As received, the estimated elective replacement indicator was at less than one month. As per the pump¿s log, lioresal with concentration 2000. 0 mcg/ml was being administered at a simple continuous dose rate of 275. 8 mcg/day as of (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the company representative (rep). The rep was not aware of any patient symptoms. It was indicated the device would be shipped back to the manufacturer on (b)(4) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving an unknown type of baclofen via an implanted intrathecal pump. The indication for use regarding the pump was intractable spasticity. It was reported that possible premature battery depletion occurred. The event date was asked, but unknown. The pump was explanted on (b)(6) 2018. It was noted that the pump was on the recall list. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. It was unknown what diagnostics/troubleshooting was performed. As an action/intervention taken to resolve the issue, it was reported that the pump was replaced. The issue was resolved at the time of the report. The patient was without injury regarding their status at the time of the report. The patient¿s medical history and weight were asked, but was unknown. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer. The pump was to be returned for analysis. On (b)(6) 2018 a company representative further reported that the pump administered baclofen with concentration 2000 mcg/ml at a dose rate of 275 mcg/day. Regarding the report of possible battery depletion and if a low battery was verified in the event logs, it was indicated that this was not verified, and it was believed the healthcare provider office assumed it was premature battery depletion since the pump was on a recall list. It was indicated that elective replacement indicator (eri) had occurred. The average daily flow rate that the pump was programmed with was 275 mcg/day. No further patient complications have been reported as a result of this event.
 
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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 Key7262322
MDR Text Key103333383
Report Number3004209178-2018-03070
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
Type of Report Initial,Followup,Followup,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2011
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2018 Patient Sequence Number: 1
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