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

Model Number	8781
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer representative regarding a patient who received morphine (10 mg/ml, unknown dose) in an implantable pump for an unknown indication for use.The catheter was observed to have a damaged tip after removal from the introducer needle during the pump implant procedure on (b)(6) 2017.All parts looked intact and a new catheter was implanted.There were no reported unusual signs or symptoms reported by the patient or hcp post procedure.There were no known environmental/external/patient factors that may have led or contributed to the issue.The issue was considered resolved as of (b)(6) 2017.The status of the patient was stated to be alive and with no injury.The catheter was not implanted and would be returned for analysis.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Eval code-conclusion was updated; code no longer applies.
Additional Manufacturer Narrative
Analysis of the catheter, model#8781, serial# (b)(4), found damage/tear at the distal end of the catheter.Also, a bend in the guide were occurred in an area 0.5cm from the distal tip.There was also some damage to the individual windings of the quidwire.The catheter and guide wire damage which occurred during the implant procedure.(b)(4).
Additional Manufacturer Narrative
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: 6228390
• Report Number: 3007566237-2017-00058
• Device Sequence Number: 13632526
• Product Code: LKK
• UDI-Device Identifier: 00643169202139
• UDI-Public: 00643169202139
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/17/2017

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: 12/18/2017
• Device Model Number: 8781
• Device Catalogue Number: 8781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/02/2017; 03/02/2017
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/01/2017; 03/17/2017; 09/28/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1