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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 Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional via a company representative regarding a catheter replacement event that occurred intra-operatively on this report date, there was an out of box failure at implant. It was reported that, intraoperatively, upon deployment of the anchor, the distal end of the anchor folded over itself and made the catheter ¿un-usable¿. A different catheter segment was used with no issue. The catheter was to be returned to the manufacturer. It was noted that at the time of the event the pump had not yet been implanted, the pump serial number was unknown. There was no patient therapy issue reported. No further complications were reported or anticipated.
 
Manufacturer Narrative
Analysis of the catheter determined the anchor did not deploy properly from the anchor deployment tool, not able to use. The catheter was returned in {x} segments.
 
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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 Key6431140
MDR Text Key101497415
Report Number3007566237-2017-01104
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 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/20/2019
Device Model Number8780
Device Catalogue Number8780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2017
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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