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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 8637-20
Device Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received and it was reported that the pump was replaced.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) indicated they were unable to read the logs after interrogation; therefore, it was unknown when the elective replacement indictor (eri), end of service (eos), and reset occurred. Upon hospital admission on (b)(6) 2017 the patient¿s weight was (b)(6) kg (unknown date). No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. The returned pump was interrogated and as per the logs the following medication was being administered via a simple continuous dose rate as of 2017 (b)(6): baclofen with concentration 2000 mcg/ml at a dose rate of 701 mcg/day. Eval code - conclusion code ¿ 92 is being updated to 11 for this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) and the device was received for analysis. The pump logs were provided and the patient was currently receiving intrathecal baclofen 2000 mcg/ml at 500. 1 mcg/day via the new pump implanted on 2017 (b)(6).
 
Manufacturer Narrative
The pump was returned and analysis found high resistance of the pump battery. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected (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
Information was received from a healthcare professional via a company representative regarding a patient receiving baclofen via an implanted pump. The indication for pump use was cerebral palsy and intractable spasticity. On (b)(6) 2017 it was reported that a pump alarm was heard. On interrogation, the attention dialogue box showed eos (end of service) occurred, reset occurred, and eri (elective replacement indicator) occurred. The eri and eos were premature. The event date was reported as 2017. The pump was being replaced emergently today. No patient symptoms were reported. No further 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 Key7078515
MDR Text Key103309404
Report Number3004209178-2017-24757
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,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2011
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: 12/04/2017 Patient Sequence Number: 1
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