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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7412955
MDR Text Key104897044
Report Number3004209178-2018-06927
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
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