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 company representative,health report with the FDA on 2020-03-30 for SYNCHROMED II 8637-40 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185489802] Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2020, product type: catheter. Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 13-jul-2012, udi#: (b)(4); product id: 8709, serial/lot #: (b)(4), ubd: 08-jun-2008, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185489803] Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving baclofen (300 mcg/ml at 177. 168 mcg/day) and morphine (25 mg/ml at 14. 764 mg/day) via an implanted pump. It was reported that last friday ((b)(6) 2020) the patient went into withdrawal. Sometime after that the patient went for a ct scan which showed catheter breakage. The catheter was replaced today ((b)(6) 2020). No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06344
MDR Report Key9896834
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-20
Date Mfgr Received2020-03-27
Device Manufacturer Date2020-01-30
Date Added to Maude2020-03-30
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 Received2020-03-30
Model Number8637-40
Catalog Number8637-40
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 2020-03-30

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