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

Model Number	8781
Medical Device Problem Codes	Component Missing (2306); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2017-oct-26, information was received from a foreign healthcare professional (hcp) via daiichi regarding a patient receiving an unknown drug from an implantable pump for an unknown indication for use.On (b)(6) 2017, during the procedure, when the hcp attempted to connect the spinal side catheter and the pump side catheter using the catheter connector, the hcp noticed that one collet was missing.Several other hcps looked for the missing college on the sterile catherostat but could not find it.Further details of the actual product complaint stated, "one collet was missing although collets should have been attached to each catheter connector on the both sides." no patient symptoms were reported.No further complications were reported and/or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2017-nov-26, additional information was received from a foreign manufacturer representative (rep).It reported the purpose of the initial implantation was for a new implant.Another catheter was used to resolve the event.There was no impact to the patient due to the missing collet.When asked about the medication in the pump, the rep stated, "only baclofen is approved in japan (no information for dose and concentration)".The missing collet was identified after the procedure began.It was not determined if the collet was lost or not included in the package.
Additional Manufacturer Narrative
Analysis of the catheter (n708817002) found the pin connector collet detached and it was unknown if it procedural or manufacturer related.If information is provided in the future, a supplemental report will be issued.
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: 7050754
• Report Number: 3007566237-2017-04915
• Device Sequence Number: 1690821
• Product Code: LKK
• UDI-Device Identifier: 00643169202139
• UDI-Public: 00643169202139
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2018

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: 03/15/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N708817002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/26/2017; 12/13/2017; 01/08/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 11/27/2017; 01/04/2018; 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1