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

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.

• Brand Name: CONCERTO CRT-D DR
• Type of Device: IMPLANTABLE PACEMAKER/CARDIO/DEFIB
• Baseline Brand Name: CONCERTO CRT-D DR
• Baseline Generic Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: C154DWK
• Baseline Device Family: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Baseline Device PMA Number: P010031
• 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 Marketed: 06/21/2006
• Manufacturer (Section F): MEDTRONIC MED REL, INC.; street1; street2; juncos PR * NI ; S
• Manufacturer (Section D): MEDTRONIC MED REL, INC.; street1; street2; juncos PR * NI; S
• Device Event Key: 772860
• MDR Report Key: 785060
• Event Key: 749139
• Report Number: 6000144-2006-00180
• Device Sequence Number: 1
• Product Code: LWS
• 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 Received: 11/10/2006
• Is This An Adverse Event Report?: No
• Device Operator: Lay User/Patient
• Device MODEL Number: C154DWK
• 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 Date: 08/01/2006
• Device Age: 3 mo
• Event Location: Hospital
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 08/01/2006
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/09/2006
• Is The Device Single Use?: Yes
• Is the Device an Implant?: Yes

Is this an Explanted Device?

• Type of Device Usage: Initial
• Removal/Correction Number: NI