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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Unstable (1667); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Headache (1880)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.(b)(4).

Event Description

Information was received from a consumer regarding a patient receiving fentanyl (unknown concentration and dose) via an implantable infusion pump.Indications for use included non-malignant pain and degenerative disk disease/herniated disc pain.It was reported that the personal therapy manager (ptm) was indicating the patient was locked out from receiving a bolus.The patient was having trouble with her ptm bolus just a couple of times, and would give her the poor communication screen; and sometimes it would act like it gave her the bolus and gave her the lockout with exactly 2 hours to wait.This started approximately (b)(6) 2015.The patient usually did boluses at night because that was when she had leg pain, but on (b)(6) 2015, the patient had the poor communication screen.The patient tried several troubleshooting options, and never got the bolus.She was getting the poor communication screen the whole time.Additional troubleshooting was performed on (b)(6) 2015, and the ptm would not connect no matter what position she put the ptm in, or even if she moved to another room.The patient lost 40 pounds on a diet since approximately (b)(6) 2015, and the pump moved all over the place, "then she puts the ptm bolus over it,," and the patient got the poor communication screen each time.The patient stated the healthcare provider (hcp) would need to re-position the pump; which was lying under her left pelvic bone, and would have to move it over.When she moved it, there was a "bunch of scar tissue lying on that pump" and the patient wondered if that was causing the ptm bolus not to be able to send the signal.The patient was not scheduled for the re-position surgery of the pump until she got back (from vacation).The patient also had a migraine for 3 days which started on (b)(6) 2015, and the patient got diagnosed with migraines 40 years ago in 1975.She would get them 4 times a year with an "aura and the sound of rustling leaves." if she could get to the doctor they would give her a shot of toradol for pain and phenergren for nausea and she would go to bed and the next day it was gone.The migraine cleared up on (b)(6) 2015.The patient also took topamax.No troubleshooting, interventions, cause of the pump movement, or outcome were 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: 5145336
• MDR Text Key: 28115369
• Report Number: 3004209178-2015-20452
• 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
• Reporter Occupation: Other
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• 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: 09/15/2015
• Date Device Manufactured: 09/13/2012
• 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: 00060 YR