LEAD END CAP KIT 5867-3M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-21 for LEAD END CAP KIT 5867-3M manufactured by Mpri.

Event Text Entries

[117755099] Concomitant medical products: 5076-58, 457453 lead, implanted: (b)(6) 2007. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[117755100] It was reported that the implantable pulse generator (ipg) system was explanted due to infection of unknown source. Antibiotic treatment was necessary. 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 Number2649622-2018-13669
MDR Report Key7801843
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-08-21
Date of Report2018-08-21
Date of Event2018-07-30
Date Mfgr Received2018-07-30
Device Manufacturer Date2016-09-22
Date Added to Maude2018-08-21
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 ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
Manufacturer G1MPRI
Manufacturer StreetROAD 149 KM 56.3
Manufacturer CityVILLALBA PR 00766
Manufacturer CountryUS
Manufacturer Postal Code00766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD END CAP KIT
Generic NameADAPTOR, LEAD, PACEMAKER
Product CodeDTD
Date Received2018-08-21
Model Number5867-3M
Catalog Number5867-3M
Lot NumberVA1ALZD
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMPRI
Manufacturer AddressROAD 149 KM 56.3 VILLALBA PR 00766 US 00766


Patients

Patient NumberTreatmentOutcomeDate
15076581. Hospitalization; 2. Required No Informationntervention 2018-08-21

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