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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8780
Device Problems Activation, Positioning or SeparationProblem (2906); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: the initial report included device code (b)(4) in error and has been removed. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis determined that the anchor did not deploy properly from the anchor deployment tool. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient receiving dilaudid (hydromorphone) 2mg/ml for a total dose of 0. 1mg/day via an implantable pump for spinal pain. It was reported that the anchor deployment tool broke when trying to deploy the anchor. It was noted that the patient was large, and the angle was steep. It was noted that t he device (anchor tool) and the anchor were removed. A new anchor was used. The issue was resolved at time of report. No symptoms were reported. No further complications were reported/anticipated.
 
Manufacturer Narrative
Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code 12 because, although the device meets design specification, medtronic made 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.
 
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Brand NameASCENDA
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7102319
MDR Text Key102728408
Report Number3007566237-2017-05112
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
Report Date 01/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number8780
Device Catalogue Number8780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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