SYNCHROMED II 8637-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for SYNCHROMED II 8637-20 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185970444] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185970445] Information was received from a healthcare provider (hcp) regarding a patient who was receiving heparin with a concentration and dose of 1 ml/ml at 0. 7 units/day and floxuridine with a concentration and dose of 1 ml/ml at 1 ml/day via implantable drug delivery pump. It was reported that the patient had a hepatic artery infusion (hai) refill on (b)(6) 2020 and came back for another refill on (b)(6) 2020. When the hcp interrogated the pump it was showing the pump was in stopped pump mode and the tube set alarm occurred on (b)(6) 2020. They were unsure if the patient heard the pump alarming. They checked the pump logs and the logs showed the update on (b)(6) 2020 but there was not a successful update (pump restarted due to restart command). Discussed incomplete telemetry, interference, movement of tele head. Hcp stated that today ((b)(6) 2020) they were changing to heparinized saline. Discussed that the patient had not received the floxuridine post (b)(6) 2020 refill. Discussed contacting the physician to update them on the situation. Discussed contacting the local mdt rep for inservicing on programming and use of the programmer 8840. Discussed new tablet. No patient symptoms or further complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06474
MDR Report Key9908075
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-30
Device Manufacturer Date2019-04-03
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
Manufacturer CityJUNCOS PR 00777
Manufacturer CountryUS
Manufacturer Postal Code00777
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNCHROMED II
Generic NamePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Product CodeLKK
Date Received2020-03-31
Model Number8637-20
Catalog Number8637-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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