SYNERGY 10602

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 2020-03-31 for SYNERGY 10602 manufactured by Boston Scientific Corporation.

Event Text Entries

[185941597] Date of birth: patient was born in the year of (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185941598] It was reported that stent damage occurred. A 2. 50 x 16 synergy drug-eluting stent was selected for use. However, stent was not properly placed on the ring and during procedure the stent got twisted on the wire. The procedure was completed with another of same device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04200
MDR Report Key9908473
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-13
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-08-28
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNERGY
Generic NameBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Product CodeNIQ
Date Received2020-03-31
Model Number10602
Catalog Number10602
Lot Number0024377318
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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