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

Model Number	8781
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
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 (b)(6) 2017, information was received from a foreign healthcare professional (hcp) via daiichi.No patient or drug information was provided.On (b)(6) 2017, during a procedure, the catheter collet came off when gripped.Details of the actual product of complaint stated, "the collet of came off from the catheter connector".Comment/request from the customer stated, "nothing in particular because a connector in an accessory kit was unpacked and used".No further information was provided.
Additional Manufacturer Narrative
Analysis of the catheter (lot#; n699882006) identified the collet was detached from the catheter to catheter connector.(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2017-dec-06, additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative (rep) and (b)(4).It reported the drug in the pump was baclofen (unknown dose and concentration).The initial reporter was an unknown physician of the hospital.It was confirmed the device issue caused no patient impact.

• 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: 7068396
• Report Number: 3007566237-2017-04993
• Device Sequence Number: 1211540
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2017

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: 02/08/2019
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Device Lot Number: N699882006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 12/27/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/13/2017; 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1