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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Failure to Interrogate (1332); Noise, Audible (3273)

Patient Problem Muscular Rigidity (1968)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 8840, serial# unknown, product type programmer, physician; product id 8703w, lot# l80503, implanted: (b)(6) 2000, product type catheter.(b)(4).

Event Description

It was reported that the healthcare provider (hcp) was unable to read the patient's pump.The hcp tried everything including changing rooms 2 different times and utilizing different clinician programmers.Earlier on the day of report, prior to sending the patient for an x-ray the hcp also had issues with reading the pump but was finally able to read it confirming the event logs were normal since the last pump refill on (b)(6) 2014.It was reported that there was nothing abnormal at the time of report and everything was fine with the x-ray.The x-ray showed catheter was intact, tubing intact, correct pump orientation and logs had no events listed since last fill.The hcp could hear the pump "ticking" and the patient had been experiencing withdrawal symptoms since approximately one week ago per the patient's mother.Symptoms included sweating, irritability and increased spasticity.It was noted that the "motor could be heard," there was no alarm and no events logged.The patient had not had any "medical procedures, radiation, hyperbaric, etc." the rooms that the patient had been in had been utilized for other pump readings on the day of report with no issues.The hcp wanted to do a catheter dye study but could not read the pump to be able to prime the catheter post procedure.The patient tried to read the pump after 5 attempts.The cause of the event was unknown, the last refill was done without issue.The plan was for pump replacement surgery.As of (b)(6) 2015, the patient had not recovered, symptoms/issue was ongoing.The pump system was delivering lioresal.(no outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.).

• 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: 4525320
• MDR Text Key: 241281057
• Report Number: 3004209178-2015-03254
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Date Device Manufactured: 06/15/2012
• 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: 00033 YR