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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 Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
Interrogation of the device revealed the pump had been programmed to deliver 1,150. 0 mcg/ml of baclofen at 174. 8 mcg/day. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The pump and catheter were returned to the manufacturer for analysis. It was indicated the reservoir was empty because the drug was transferred to the replacement pump at surgery on (b)(6) 2017.
 
Manufacturer Narrative
The pump was returned for analysis. During decontamination in the lab, a low battery reset occurred. Destructive analysis identified a high battery resistance during functional testing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative on (b)(6) 2017 regarding a patient receiving compounded baclofen (1100mcg/ml at 174. 8mcg/day) via an implanted infusion pump. The indications for use included intractable spasticity and spinal cord injury/spinal cord disease. It was reported that the elective replacement indicator (eri) was occurring unexpectedly. The alarm was heard and confirmed by telemetry, and it was noted that the eri was premature. The event date was noted to be (b)(6) 2017. It was noted that the alarm was not silenced but it should be fine since the patient could barely hear it. The pump was reportedly still infusing as of the date of report. No patient symptoms were reported, and it was noted that they had a potential date to replace the pump on (b)(6) 2017. No further complications were reported or 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 Key7109638
MDR Text Key102127739
Report Number3004209178-2017-25861
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
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 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2276-2009, Z-3043-2011

Patient Treatment Data
Date Received: 12/12/2017 Patient Sequence Number: 1
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