MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

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

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

Event Type  malfunction  

Event Description

It was reported when trying to read the pump it would not read.The patient turned off her implantable neurostimulator (ins) charger and the healthcare provider (hcp) was able to get a read.It was also reported when the hcp came in to do an adjustment of the pump they could not get a read again and the patient had to turn off her stimulation to be able to do an adjustment on the pump.The pump was being used to deliver fentanyl, morphine, and an unknown drug.Additional information has been requested; a follow-up report will be sent when it becomes available.

Manufacturer Narrative

Concomitant: product id 8840, serial# (b)(4), product type programmer, physician.Product id 8731sc, serial# (b)(4), implanted: 2012-(b)(6), product type catheter.(b)(4).

Event Description

Additional information received from the patient reported that the stimulation needed to be off when the pump was programmed or the settings would be incorrect.The patient turned off the stimulation and the pump cleared ((b)(6) 2012) the unknown drug was reported as bupivacaine.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• 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: 3786463
• MDR Text Key: 4362446
• Report Number: 3004209178-2014-08418
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• Date Device Manufactured: 12/16/2011
• 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