MAXIMO II CRT-D D284TRK

Adverse Event reported on 10/31/2012

Device Attributes
AttributeValue
ManufacturerMEDTRONIC MED REL, INC.
Brand NameMAXIMO II CRT-D
Device TypeIMPLANTABLE PACEMAKER/CARDIO/DEFIB
Product CodeNIK
Model NumberD284TRK
Catalog Number
Device Operator0LP
MEDTRONIC MED REL, INC. MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB   Back to Search Results
Model Number D284TRK
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative

The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Evaluation summary: (b)(4) actual longevity is < 80%="" of="" 99.="" 9%="" longevity="" limit.="" the="" device="" was="" returned="" and="" analyzed.="" the="" device="" was="" fully="" functional,="" with="" no="" high="" current="" drain="" or="" evidence="" of="" battery="" problems.="" without="" the="" history="" of="" the="" programmed="" settings="" throughout="" its="" service="" life,="" there="" is="" no="" way="" to="" determine="" why="" the="" longevity="" did="" not="" match="" the="" predicted="" model.="">

 
Event Description

It was reported that the device was reached elective replacement indicator (eri) much more quickly than expected. The device was explanted and replaced. No patient complications have been reported as a result of this event.

 
Source: FDA