MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; LEGGING, COMPRESSION, NON-INFLATABLE

Model Number 8780

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8637-20, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: pump.(b)(4).

Event Description

Information received from a healthcare provider (hcp) via manufacturer representative regarding a patient receiving dilaudid (unknown dose/concentration).Indication for use was noted as spinal pain.It was reported that there was a catheter event.A dye study was performed because the patient was having volume discrepancies at refills.The dye study prompted a catheter revision that led to a replaced of the catheter on (b)(6) 2015.The exact volumes were unknown but they were getting back more than expected.The manufacturer representative believed the volume discrepancies went back to october of 2015.While in the case the physician decided to replace the pump as well.The patient was doing well per the manufacturer representative.No symptoms were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative (rep).While it was reported that during refill there was more drug taken out than on the 8840 (physician programmer) printout, the specific volumes were still not specified.It was reported there was no patient injury, and that the patient recovered without sequela following the replacement.No further information was provided.

Manufacturer Narrative

Concomitant product(s): product id: 8637-20, serial# ngp377003h, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: pump.The previously reported indication for use, spinal pain, is being corrected to non-malignant pain.Analysis of the returned catheter segment found a non-significant anomaly, specifically a tear in the seal of the sc (sutureless) connector near the guide ring.Upon return, the device was interrogated and was found to have been programmed with dilaudid 15.0mg/ml at a dose of 5.498 mg per day, bupivacaine 15.0mg/ml at a dose of 5.498 mg per day and clonidine 750 mcg/ml at a dose of 274.91 mcg per day.The previously reported conclusion code is being updated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• Type of Device: LEGGING, COMPRESSION, NON-INFLATABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5369106
• MDR Text Key: 36027887
• Report Number: 3007566237-2016-00312
• Device Sequence Number: 1
• Product Code: LLK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2015
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00053 YR