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

Model Number	8781
Medical Device Problem Codes	Connection Problem (2900); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter postal code:(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care professional (hcp) via a business partner regarding a patient in (b)(6).The indication for use spasticity.It was reported that the collect of the catheter connector in the ascenda kit came off.As further clarified, when an attempt was made to connect the spinal side catheter and the pump side catheter using a catheter connector during the initial pump implantation operation, the collet was found ¿to be come off¿ from the connector.In this facility, the package of the ascenda catheter set was unpacked by a nurse, and not the business partner representative.Therefore the business partner representative could not confirm the defect of the product at that time.The product was never implanted.The causality was associated to the product itself.This product was replaced with another back-up accessory kit.Patient symptoms were not reported.At the time of the report the issue was resolved and the patient¿s status was reported as alive-no injury.As reported, it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the event.The cause could not be specified ¿on the spot¿.As reported there was no product for analysis.It was unknown if the returning the product was requested to the customer.No further complications were reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the catheter found that the pin connector/collet was detached and-or missing.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: 7422796
• Report Number: 3007566237-2018-01061
• Device Sequence Number: 13461651
• 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
• Report Date (Section B): 06/18/2018

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: 06/27/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N734404003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/15/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/18/2018; 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1