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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL, INC.CONCERTO CRT-D DRIMPLANTABLE PACEMAKER/CARDIO/DEFIB

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MEDTRONIC MED REL, INC. CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB   Back to Search Results
Model Number C154DWK
Device Problem Rate modulated pacing sensor, failure of
Event Date 08/01/2006
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative

Attempts were made to obtain additional information from the user facility regarding this event. The information submitted reflects all relevant data received. Notification that this event does not meet the user facility's reporting criteria will be filed internally if it is received after this report is submitted. Evaluation summary: pvr401939h no anomalies were found.

 
Event Description

It was reported 30 minutes post implant that the pacing rate was 130 ppm with rate response on. With rate response off normal rates were observed. There was no environmental source noted in the room that would drive up the sensor rate. The following day the device was functioning normally, but was still explanted. No further patient complications were reported as a result of this event.

 
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Brand NameCONCERTO CRT-D DR
Type of DeviceIMPLANTABLE PACEMAKER/CARDIO/DEFIB
Baseline Brand NameCONCERTO CRT-D DR
Baseline Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Baseline Catalogue NumberNA
Baseline Model NumberC154DWK
Baseline Device FamilyIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Baseline Device PMA NumberP010031
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)18
Date First Marketed06/21/2006
Manufacturer (Section F)
MEDTRONIC MED REL, INC.
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Manufacturer (Section D)
MEDTRONIC MED REL, INC.
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juncos PR * NI
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Device Event Key772860
MDR Report Key785060
Event Key749139
Report Number6000144-2006-00180
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Invalid Data
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2006
Is This An Adverse Event Report? No
Device Operator Lay User/Patient
Device MODEL NumberC154DWK
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/01/2006
Device Age3 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/01/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/09/2006
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial
Removal/Correction NumberNI

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