MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO CONCERTO II CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D274TRK

Device Problems Premature Discharge of Battery (1057); Nonstandard Device (1420); Output above Specifications (1432)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported the device had possible early battery depletion.It was also indicated that the right ventricular output had been set at 3.5 volts at 1 millisecond for the life of the device.The device was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the device was returned and analyzed.The device was returned and analyzed.The device met 88% of expected longevity.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.This device was included in a field action, but returned product testing found the device did not perform as described in the field action.Concomitant medical products: 507645, implantable pacing lead, (b)(6) 2005; 419478, implantable pacing lead, (b)(6) 2005.(b)(4).

• Brand Name: CONCERTO II CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3614450
• MDR Text Key: 4170998
• Report Number: 3004209178-2014-01906
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2011
• Device Model Number: D274TRK
• Device Catalogue Number: D274TRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2013
• Initial Date FDA Received: 02/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0110-2011
• Patient Sequence Number: 1
• Treatment: 694958 IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00067 YR