CAPSURE VDD-2 LEAD 5038

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-13 for CAPSURE VDD-2 LEAD 5038 manufactured by Mpri.

Event Text Entries

[183252708] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183252709] It was reported that the right atrial (ra) lead exhibited oversensing and rising impedance. Rising thresholds were also noted on the lead since the patient experienced a fall. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[185384265] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185384266] It was further reported that the right atrial (ra) lead was reprogrammed and the patient is scheduled for a replacement in future.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2649622-2020-05224
MDR Report Key9828511
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-13
Date of Report2020-03-26
Date of Event2020-02-27
Date Mfgr Received2020-03-24
Device Manufacturer Date2003-10-02
Date Added to Maude2020-03-13
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
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 NameCAPSURE VDD-2 LEAD
Generic NamePULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Product CodeDXY
Date Received2020-03-13
Model Number5038
Catalog Number5038
Device Expiration Date2005-09-12
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
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
101. Required No Informationntervention 2020-03-13

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