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

Model Number	8709SC
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	04/19/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant components include: product id: 8637-20, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: pump.
Event or Problem Description
Information was received from a consumer regarding a patient receiving unknown drug via an implanted pump.The indication for use was non-malignant pain.It was reported the patient had a catheter failure in the past and the catheter was revised on (b)(6) 2012.It was noted the patient had withdrawal due to the catheter failure.No further complications anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INDURA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6429524
• Report Number: 3007566237-2017-01099
• Device Sequence Number: 13463225
• Product Code: LKK
• UDI-Device Identifier: 00613994586056
• UDI-Public: 00613994586056
• Combination Product (Y/N): N
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2013
• Device Model Number: 8709SC
• Device Catalogue Number: 8709SC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR