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

Model Number	8780
Medical Device Problem Codes	Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2015, product type: pump.This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who received unknown morphine (20mg/ml, 6.9887mg/day) and bupivacaine (20mg/ml, 6.9887mg/day) in an implantable pump for chronic low back pain and spinal pain.A pocket revision occurred on (b)(6) 2016 due to a flipped pump.X-rays were reportedly performed at a previous date, results were not reported.The issue occurred for a few months where the patient could manually flip the pump.The cause of the pump movement was unknown.The patient experienced a bruised abdomen around the pump.When the pump segment "came apart" and a forceps was needed to disconnect from the pump.The pump segment was also "pretty coiled up" and was replaced with a proximal revision kit.A mesh pouch was also added.The existing distal catheter segment was easily aspirated and remained.The pump was reservoir was aspirated and the actual residual volume was 40ml, expected residual volume was 19.7ml.The issue was considered resolved at the time of report.The daily dose was decreased to 0.960mg/day.The patient's status at the time of the event was stated to be alive with no injury.
Additional Manufacturer Narrative
Analysis of the catheter, model# 8780, serial# (b)(4), found significant twisting that may have affected infusion.A kink was also seen on the catheter body where twisting was observed.The are occluded during pressure testing when bent to a narrow radius.The transition tubing was also noted to be damaged.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: 5520368
• Report Number: 3007566237-2016-00800
• Device Sequence Number: 16762278
• Product Code: LKK
• UDI-Device Identifier: 00613994555595
• UDI-Public: 00613994555595
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2016

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: 03/27/2017
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Initial Date Received by Manufacturer: 01/20/2016
• Supplement Date Received by Manufacturer: 03/22/2016; 03/22/2016
• Initial Report FDA Received Date: 03/23/2016
• Supplement Report FDA Received Date: 03/23/2016; 09/20/2017
• 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: 61 YR