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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient was using their personal therapy manager (ptm) for the first time on their own, and they said it was not going through.They were seeing the poor communication screen.They did not have an antenna.They were able to receive bolus doses on the day prior to this report, but sometimes it took a couple of tries.Today was when they really noticed the issue.As of (b)(6) 2014, the patient was trying to give themselves a bolus, but the ptm kept beeping, and they then saw the poor communication screen.They stated this just started happening on the morning of (b)(6) 2014.The patient also reported a sharp pain in the area of their pump, and they were now questioning if their pump had flipped.The pump was pretty superficial and was not too deep.They were to schedule an x-ray to determine the pump¿s orientation.As of (b)(6) 2014, it was determined that the cause of the ptm issue was that the patient¿s pump was flipped.The pump was corrected, as it was flipped back into place.The patient was to continue wearing an abdominal binder.At the time of this report, the patient had recovered without permanent impairment.The pump contained morphine.Troubleshooting/diagnostics and specific interventions/treatment were not reported.Further follow-up was conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

Right after pump implant the patient was getting some pain relief, but since then she had not been getting the expected pain relief.A dye study was performed and magnetic resonance imaging (mri) was scheduled to be performed to check the catheter.It was noted that the pump first had only morphine and on (b)(6) 2015 bupivacaine was added.The patient was having ¿some major problems with the pump not working for her.¿ they had increased the ¿quantity of boluses 6-7 times.¿ the patient had no relief no matter how much they increased the medication.Approximately 2 weeks after the pump was implanted the pump flipped over because of the loose skin in the area.The pump was flipped back over.On (b)(6) 2015, they ¿flushed unit out¿ and gave the patient a fentanyl patch.The reporter stated that if the patch worked, they would know something was wrong with the pump.As of (b)(6) 2015, the reporter did not know if any medication was in the pump.

Manufacturer Narrative

Concomitant products: product id 8835, serial # (b)(4), product type programmer, patient; product id 8780, serial # (b)(4), implanted: (b)(6) 2014, product type catheter.(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4402153
• MDR Text Key: 5127953
• Report Number: 3004209178-2015-00409
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• 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: 03/11/2015
• Date Device Manufactured: 10/06/2014
• 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: 00084 YR