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

Model Number	8780
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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.

• Brand Name: ASCENDA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7102319
• Report Number: 3007566237-2017-05112
• Device Sequence Number: 13808812
• Product Code: LKK
• UDI-Device Identifier: 00643169202122
• UDI-Public: 00643169202122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/15/2017; 01/18/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 12/15/2017; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR