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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 11/27/2017
Event Type  Injury  
Manufacturer Narrative
Analysis found that there was a feedthru anomaly with a shorting across the insulator in the pump motor. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code (b)(4) because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event. 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 a healthcare professional (hcp). It was reported that the cause of the premature elective replacement indicator (eri) was not determined. The premature eri was resolved and the pump was replaced.
 
Manufacturer Narrative
Interrogation of the pump determined it was used to infuse baclofen at concentration of 4,000. 0 mcg/ml. : analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. 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 professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving an unknown drug via an implantable infusion pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported that an alarm was heard and confirmed by telemetry for elective replacement indicator (eri) on (b)(6) 2017. It was confirmed that eri was occurring and it was not expected. When the pump was interrogated in (b)(6) 2017, it said that eri was 35 months and now it was reading zero months left. The patient had a replacement scheduled for next week thursday. No symptoms were reported and no further complications were expected 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 Key7067787
MDR Text Key102370861
Report Number3004209178-2017-24532
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,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1579-2013

Patient Treatment Data
Date Received: 11/29/2017 Patient Sequence Number: 1
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