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

Model Number 8637

Device Problems Electromagnetic Interference (1194); Difficult to Interrogate (1331); Failure to Interrogate (1332)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a company representative (rep) regarding a patient receiving an unknown intrathecal medication via an implanted pump for no an unknown indication.The reporter was not able to get complete telemetry while updating the new pump.It reached about ¾ of the way before it stopped.Troubleshooting done prior to the call included trying to update the pump multiple times and had also tried using a different 8840 clinician programmer as well with no success.Troubleshooting done on the call included eliminating and moving away from potential sources of interference and change environment, if appropriate.It was reviewed to turn off the lights in the operating room (or) since they were updating in the or.The rep had stopped away from the or room to get service for this call so he would try these troubleshooting steps and call back if it was not successful.Patient symptoms were not reported.The event date was (b)(6) 2018.The rep had no further information since she was away from the room.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Concomitant medical products: product id: 8840, product type: programmer, physician.Product id: 8840, product type: programmer, physician.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) indicated they had no further information to provide and the issue was resolved when the c-arm was shut down.No further complications were reported/anticipated or expected.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7589482
• MDR Text Key: 110730283
• Report Number: 3007566237-2018-01747
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/29/2018
• 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