TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT 5866-38M

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 2019-03-26 for TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT 5866-38M manufactured by Medtronic, Inc..

Event Text Entries

[139871444] Concomitant medical products: 5071-53 lead; 5071-53 lead, implanted: (b)(6) 2014. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[139871445] It was reported that the patient experienced an infection. The cardiac resynchronization therapy defibrillator (crt-d), right atrial (ra) lead and right ventricular (rv) lead was removed. The left ventricular (lv) leads were capped. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182208-2019-00576
MDR Report Key8452478
Report SourceHEALTH PROFESSIONAL
Date Received2019-03-26
Date of Report2019-04-03
Date of Event2019-01-25
Date Mfgr Received2019-03-26
Device Manufacturer Date2014-08-25
Date Added to Maude2019-03-26
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 ROBERTSON
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635262723
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT
Generic NameADAPTOR, LEAD, PACEMAKER
Product CodeDTD
Date Received2019-03-26
Model Number5866-38M
Catalog Number5866-38M
Device Expiration Date2016-08-20
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-03-26

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