SYNCHROMED II 8637-40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185803636] Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185803637] Information was received from the consumer regarding a patient receiving an unknown drug via an implantable infusion pump. It was reported that the patient's body rejected the pump about 4-5 weeks after insertion. It was noted that the patient developed a bad infection and the pump was surgically removed. It was stated that the patient had an allergy to nickel and wondered if the pump contained any. No further complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06445
MDR Report Key9902969
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2018-04-16
Date Mfgr Received2020-03-28
Device Manufacturer Date2018-02-13
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 Number8637-40
Catalog Number8637-40
Device Expiration Date2019-07-28
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
101. Required No Informationntervention 2020-03-31

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