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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8590-1, lot# n499997, implanted: (b)(6) 2014, product type: accessory.Product id 8835, serial# (b)(4), product type: programmer, patient.Product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id 8835, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

The patient reported the personal therapy manager (ptm) displaying code 8503.The pump was recently refilled.A new medication (dilaudid) was put in the pump.There was a 24-hour programmed bridge bolus duration, and the patient thought it had been 48 hours since the bridge bolus.The patient had not tried to receive a bolus until (b)(6) 2015.It was noted that the patient's old health care provider (hcp) discontinued the ptm and was titrating the intrathecal dose down (per the patient), but the patient's most current hcp re-introduced the ptm to the patient.The patient also reported an antenna jack issue.There was a loose antenna jack.They were getting the poor communication screen and no telemetry.They tried new batteries.There was no out of box failure reported.A manufacturing representative was wondering if telemetry could be affected if the pump was flipped.The rep stated the patient's pump had flipped in the past, but then clarified that it just moved around somewhat.The patient stated the pump had always done that since implant and that, apparently, a new hcp was going to tack it down at some point.The rep tried both with and without an antenna.It was noted that the rep was able to get telemetry successfully with the clinician programmer (8840).The patient was sent a new ptm and was going to try the new ptm and confirm that it communicated with the pump.The patient was not able to couple the new ptm with the pump.The new ptm was not able to connect, and the patient saw a "dr icon" with code 0617 on the new ptm.Eventually the patient connected and was okay.The patient was able to receive a bolus.(b)(6) 2015 was the patient's refill date.The patient mentioned that the pump moved around because it was not secured, and it was hard to communicate with the ptm.The patient went to the hospital on (b)(6) 2015 for an x-ray to check if the pump had flipped.The x-ray determined the pump was not flipped.The patient's bolus in formation was "4x day, 4x 120min, 1x 2hrs." the indication for use was spinal pain.The system was delivering fentanyl at an unknown concentration and reported dose of "8.01 mcg" and bupivacaine at an unknown concentration and dose.The lot numbers were unknown.Symptoms, steps taken to resolve the pump moving, and the patient's outcome were unknown.Follow up is being conducted.If additional information becomes available, the event will be updated.

Event Description

The patient later reported that the ptm would not give a bolus, it would take 4-5 times before giving a bolus.The antenna was also broken with no visible signs of damage but the patient stated maybe the internal wiring was damaged.Conflicting information on date of event, new information states antenna issue and ptm issue occurred in 2016.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5087986
• MDR Text Key: 26177676
• Report Number: 3004209178-2015-18253
• 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,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Date Device Manufactured: 07/23/2014
• 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: 00051 YR