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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954); Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care professional regarding a patient who was receiving baclofen (concentration 1000 mcg/ml, dose 284 mcg/day) via an implantable pump for intractable spasticity and movement disorders.The actual residual volume (arv) was greater than the expected residual volume (erv).On (b)(6) 2016, arv: 13 erv: 7.8.On (b)(6) 2016, arv: 13.5 erv: 8.2.On (b)(6) 2016, arv: 12.5 erv: 7.8.On (b)(6) 2017, arv: 12 and erv: 6.7.There were no symptoms reported; the patient was doing fine clinically and they had not noted any changes in therapy effect.Additional information received on 2018-feb-27 from the health care professional indicated that there was no troubleshooting performed, they would continue to monitor the patient, it was noted that the cause of the volume discrepancies was not determined and the volume discrepancies had not been resolved.Additional information was received from a healthcare provider on 2018-mar-14.It was reported that a volume discrepancy occurred.The actual reservoir volume (arv) was 10.5 ml and the expected reservoir volume was 5 ml.It was reported that the volume discrepancies that were reported last year (initially reported on 2017-feb-23) continued to occur.The caller repeated some of the discrepancies that were previously reported, but stated that the volume discrepancies are fairly consistent at around 5 -6 mls.The event date was asked but unknown.It was stated that the discrepancies have been occurring for a long time, possibly since the revision; however, they did not look back to see if they occurred prior to the revision.Troubleshooting was done prior to the call.The pump logs were checked and the reservoir was accessed.The caller stated that they didn't see anything outstanding in the logs, but noted that they were not checked all the time.It was reported that there was one motor stall and motor stall recovery in the logs, but the caller believed this was due to magnetic resonance imaging (mri).It was stated that the patient was not having any problems with the therapy, and this seems to be how the system has functioned since implant in 2013 when the pump was replaced.The caller was redirected to follow-up with the hcp, as she was planning on ordering a dye study, but wanted to confirm that is what the manufacturer would suggest.Technical services confirmed that a dye study would be next step if they have ruled out the pump as a potential cause.It was noted that the patient was receiving baclofen, and that the dose had been increased to 343.9 mcg/day from the previously reported dose.There were no symptoms reported, and it was stated that the patient is doing fine clinically.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 healthcare provider on (b)(6) 2018.It was reported that the revision occurred on (b)(6) 2013 (date of pump implant).It was confirmed that the motor stall was due to an mri, and that a recovery occurred.It was clarified that the reason for the revision was due to the "discrepancies for a while." it was indicated that the patient did not experience any symptoms related to the revision.It was unknown if any diagnostics were performed related to the volume discrepancies.The cause of the volume discrepancies was not determined.It was indicated that no actions/interventions were taken to resolve the volume discrepancies; however, it was noted that a dye study was done (no date provided).The volume discrepancies had not been resolved.Regarding the current status of the devices, it was stated that the catheter was intact, and the pump was "functionality." no further complications were reported or anticipated.

Manufacturer Narrative

H6 - eval code-conclusion 92 no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer and a hcp via a manufacturer representative.It was reported that they were getting back little over 11ml instead of 6ml.The patient repeated this had been happening for a little over a year.The patient had a refill on 2018-(b)(6) and the same volume discrepancy happened.The patient had an appointment on 2018-(b)(6) to have it "swapped out." per the patient, the hcp talked about "the gears on the inside of the pump, something like that." at the 2018-(b)(6) refill, they filled the pump to capacity.On 2018-(b)(6), they expected to get 38.7ml but actually got 40ml.At this point, the pump was programmed to infusion baclofen 1000mcg/ml at 344mcg/day.There were no further complications reported at this time.

• 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: 7412955
• MDR Text Key: 104897044
• Report Number: 3004209178-2018-06927
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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?: Yes
• Date Manufacturer Received: 10/25/2018
• Date Device Manufactured: 08/02/2013
• 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): Required Intervention
• Patient Age: 42 YR