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

Model Number 863720

Device Problem Difficult to Interrogate (1331)

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

Event Type  malfunction  

Event Description

It was reported that a pump was replaced due to regular eri (elective replacement indicator).The reporter had trouble interrogating the pump with the clinician programmer prior to the explant.The patient stated that was how it had always been for the life of the pump, and that every time someone went to read his pump it would take a while to make a connection.There was no ¿obvious reason¿ for the difficulty interrogating, and the reporter noted that the pump had been very superficial and the patient had minimal adipose tissue.The patient was alive with no injury and there were no patient symptoms or complications associated with this event.No troubleshooting, intervention, or other actions were taken were taken to resolve the event.The pump was completely replaced (b)(6) 2014.Other medications that the patient was taking at the time of the even were unknown.The reporter did not know whether the patient was receiving effective therapy at the time of this report.The pump had been used to infuse morphine and sufentanil.

Manufacturer Narrative

Concomitant medical products: product id 8709, lot# j0039913r, implanted: (b)(6) 2000, product type: catheter; product id 8578, serial# (b)(4), implanted: (b)(6) 2014, product type: accessory; product id 8840, lot# unknown, product type: programmer, physician.(b)(4).Analysis of the pump serial number (b)(4) found gear train anomaly, corrosion and/or wear and/or lubrication.Analysis found gear train anomaly, stall due to gear wheel 3.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4281869
• MDR Text Key: 5035560
• Report Number: 3007566237-2014-03440
• Device Sequence Number: 1
• Product Code: LKK
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2009
• Device Model Number: 863720
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2008
• 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 Age: 00049 YR