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

Model Number 8781

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

It was reported the anchor dispenser problem; the dispenser was not working properly.The healthcare professional (hcp) was unable to release the anchor from the dispenser and the anchor broke.It was noted another product was used, but the catheter was implanted.The pump was used to deliver morphine.There were no reported patient symptoms.The outcome of the event was not reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the pump revealed that the catheter/anchor did not properly detach from the ascenda tool/not able to use.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4362665
• MDR Text Key: 5118858
• Report Number: 3007566237-2014-03787
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2015
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: 0207705893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1