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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591); Application Program Problem (2880); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Underdose (2542); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

Other components include: product id: neu_ptm_prog, serial# unknown, product type: programmer, patient.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) and a consumer via a manufacturer's representative regarding a patient who was receiving 375 mcg/ml of fentanyl at 420.57 mcg/day and 14 mg/ml of bupivacaine at 15.701 mg/day via an implantable pump for non-malignant pain.On (b)(6) 2017, it was reported that the patient's personal therapy manager (ptm) was indicating that the patient was locked out from receiving a bolus and the patient's pump is having volume discrepancies at their refills.It was reported that the patient's boluses were unexpectedly declined and the patient was being denied intended patient-administered (pa) boluses.The patient reports when they request a bolus, they will see 59 minutes or 1 hour left for the next pa, but the patient has not been given a bolus within that hour.It was unknown if the patient utilized an antenna with their programmer.According to the ptm programming, the patient is allowed to receive 6 pa boluses a day, but the most the patient is taking is 1 or 2 a day.The patient's ptm did not appear to be utilized much.An uplink issue on (b)(6) 2017 at 2059, confirmed on the ptm technical reports and logs, was reported and identified as one of the reasons for being denied intended pa boluses.This issue reportedly began roughly 3 months prior to the date of the report.Around this same time frame, 3 months prior, the patient noted that, during pump refills, there is extra drug left in the pump reservoir.No symptoms were reported.Additional information was received on 2017-aug-14 from the patient's healthcare provider via a manufacturer's representative.The patient's ptm serial number was unknown.The patient reported changes regarding these issues approximately 3 months ago.The exact volumes involved in the volume discrepancies, the cause of the volume discrepancies, the actions taken to resolve the volume discrepancies, and the resolution of the volume discrepancies were all unknown.It was reported that an intl code was observed on the patient's ptm, which was identified as an uplink communication problem.It was suggest that an antenna be provided to help with the communication problem.The cause of the lockouts/bolus denials were unknown.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer regarding a patient receiving intrathecal fentanyl and bupivacaine.The dose and concentration was noted to be ¿375 for fentanyl".The drug information had been the same since the beginning, and there had not been any changes to concentration or flow rate.Additional dose and concentration information was unknown.It was reported that the personal therapy manager (ptm) exhibited intermittent functionality; the unit flipped from screen to screen and had issues giving a bolus.The patient was in terrible pain; his "back was killing him" because he could not get a bolus.The ptm seemed to lock him out when he needed it most (around 10p, 11p, 12a at night).It was noted that the patient ¿just went to bed and stuck it out¿.The patient had been having problems with the ptm because the ptm did not want to work and locked him out.The patient had a 1-hour time frame for bolus duration (could not do anything sooner than an hour), but the ptm would lock him out with 1 hour remaining.¿a couple of days later¿, if he tried to give himself a bolus, he would get locked out for 59 minutes, as if the ptm had just given them a bolus, but it had not given him a bolus.A manufacturing representative gave the patient a ptm antenna that worked for a while (did not get any descending tones or lockouts for a couple of weeks, got one lockout, but it was fine for another week), but now the ptm was locking him out again.On the night of (b)(6) 2017, the patient tried to get a bolus but got locked out for 1 hour.The patient tried to give himself one again, and it said ¿59 minutes¿.On the night of (b)(6) 2017, the patient was locked out 3 times.A lot of times, it would give him the descending tones with 1 hour or 59 minutes, as if it had given him a bolus.The patient had been dealing with lockouts "not longer after they put the new pump in" (probably 2 years ago) [from (b)(6) 2017).It was also reported that the ptm displayed code 0618 or 0168 (patient did not remember) when he got locked out of his pump ¿maybe 2-3 nights ago¿ (from (b)(6) 2017).The patient never saw codes before the "0618" code appeared; it just had the descending tones.The patient turned the ptm off/on, then tried to give himself a bolus and heard the ascending tones (was successful).It was noted that the patient had the pump refilled every 3 weeks, and that the ptm took a certain amount of time to reload/update when he got that refill.Lately, he noticed that for his bolus (even when successful), the "timer bar" would stop, go, and then stop, as opposed to just steady reading with sending the information.The patient had changed the batteries approximately 2.5 weeks ago, and the battery for the ptm was "half full".The patient was using duracell alkaline batteries.The device manufacturer repair department was alerted of the issue.It was also noted that there was an ongoing problem with the pump; the pump was not delivering 10-40% of the medication to him ("too much medication at change time").The patient was told by their healthcare provider (hcp) (through the device manufacturer) that it was common to have up to 35% of the medication be off each month.There were no [additional] symptoms or patient harm reported.The event date of the ptm "acting goofy" was ¿6-8 months¿ (from (b)(6) 2017).The event date of the terrible pain/back killing the patient was unknown.It was noted that the patient used his ptm every day.No out of box failure was reported.There was no allegation of a medical or therapy problem related to smalls parts.The patient was redirected to follow up with their hcp to address concerns with the symptoms reported.

• 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6792842
• MDR Text Key: 83145583
• Report Number: 3004209178-2017-17425
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• 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: 12/18/2017
• Date Device Manufactured: 11/13/2013
• 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 Age: 56 YR