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

Model Number 8637-40

Device Problems Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667)

Patient Problems Overdose (1988); Weakness (2145); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 10/14/2013

Event Type  Injury  

Event Description

It was reported that the patient¿s pump had been flipping since implant on 2013 (b)(6).At the last pump refill on 2014 (b)(6) the nurse could not get the pump filled because the pump was flipped.The patient had been wearing a belly band to keep the pump from flipping but it had not helped.For the past couple weeks prior to the report, the patient had difficulty performing telemetry with her personal therapy manager (ptm).The patient stated that at times, she would go a day or so feeling as though she was not receiving any therapy and then suddenly would ¿get a lot all at once¿.The patient stated this had been occurring for approximately 1 month.In (b)(6) 2014, the patient had asked the doctor to decrease her dose of fentanyl since she had been ¿feeling it in her face¿, which she did not expect.The patient stated that the first couple weeks after implant she felt fine and was up walking around.The more the pump moved, the more pain she had and the less she could walk.The patient had been off her feet for ¿a couple months now¿ due to the poor therapy.The patient felt weak and for the past month her ¿heart has been hurting¿.The patient began having ¿problems¿ with her heart after implant; however, the doctor told her it was a pre-existing condition that showed up in coincidence with the pump implant.The patient had an appointment scheduled with a cardiologist.The patient noted that she was taking oral oxycodone for breakthrough pain and the doctor had decreased the dose of oxycodone by 2/3 since pump implant.The device system currently delivered fentanyl.Additional information has been requested but was not available at the time of this report.

Manufacturer Narrative

Product id 8835, serial# (b)(4), implanted: 2013 (b)(6); product type programmer, patient product id 8780, serial# (b)(4), implanted: 2013 (b)(6); product type catheter.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported there was a change in therapy effect.The reporter stated the pump was not flipped and they were going to troubleshoot the system today.It was noted a catheter dye study was going to be performed.It was further noted the patient had been complaining of inconsistent and inadequate pain control for about a month.Additional information received reported that the manufacturing representative was assisting with a catheter access port (cap) dye study.The reporter stated the patient's healthcare professional (hcp) accessed the cap accurately, but they were unable to aspirate or inject fluid through the cap.It was noted the hcp stated the cap kit was patent and the needle position was correct.It was further noted that there were no volume discrepancies at refill three weeks ago.Additional information received reported the patient had a return of pain.The reporter stated the cause of the difficulty filling and aspirating were unknown at the time of this report.It was noted the patient was going in for a catheter revision in a few weeks.It was further noted that any catheter issues were unknown and the exact location of the issue was unknown at the time of this report.The reporter stated there had not been any troubleshooting conducted other than the attempt to do the catheter study.The reporter further stated it was unknown how the patient was doing and if they were receiving therapy.It was noted the pump contained fentanyl and the patient's hcp had recently programmed the pump at minimum rate.Additional information was requested, but was not available as of the date of this report.

• 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: 3685171
• MDR Text Key: 21730536
• Report Number: 3004209178-2014-04566
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• 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: 03/06/2014
• Date Device Manufactured: 07/31/2013
• 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): Other; Required Intervention