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

Model Number	8780
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and analysis found that the handle separated from the hypo tube of the anchor deployment tool.
Event or Problem Description
Information was received from a healthcare professional via a manufacturer¿s representative regarding a patient¿s implantable infusion pump system.It was reported on (b)(6) 2016 that during a procedure the anchor tool would not allow for deployment.It was reported that the t portion of the injex system did not work and troubleshooting was attempted; the healthcare provider tried to realign the t piece, but was unable to get deployment to occur.A second catheter kit had to be opened to obtain an anchor.The issue was resolved at the time this event was reported.The patient was being medicated through the pump with morphine at a concentration of 5mg/ml, and a dose of 0.9mg/day.The patient¿s medical history was unknown.No symptoms were reported.
Additional Manufacturer Narrative
The conclusion code was updated.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because it is the closest code available with respect to this event.
Additional Manufacturer Narrative
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: 6148320
• Report Number: 3007566237-2016-04270
• Device Sequence Number: 18960205
• Product Code: LKK
• UDI-Device Identifier: 00643169202122
• UDI-Public: 00643169202122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2016

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: 02/18/2018
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 12/07/2016; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR