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

Model Number D224TRK

Device Problem Battery Problem (2885)

Patient Problem Congestive Heart Failure (1783)

Event Type  Injury  

Event Description

It was reported by the patient that ¿a lead wire drained the battery on the device¿ and understood ¿both device and lead were defective within 2 ½ years.¿ he states he has been in and out of hospitals due to device malfunction and has had numerous visits for congestive heart failure.No further information was able to be obtained.The device was explanted and replaced, and the pace/sense portion of the right ventricular (rv) lead was replaced by a new pace/sense lead.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.Concomitant products: 6250c02 adaptor (b)(6) 2010; yrirhxc16115 x2 abdominal stent graft (b)(6) 2010; yrbrhxc2816135 abdominal stent graft (b)(6) 2006; ilxc1824115 abdominal stent graft (b)(6) 2006; ilxc1822115 abdominal stent graft (b)(6) 2006; 5076 implantable pacing lead (b)(6) 2010; 4196 implantable pacing lead (b)(6) 2010; 6944 implantable tachy lead (b)(6) 2010.(b)(4).

• Brand Name: CONSULTA 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: 3616504
• MDR Text Key: 19769092
• Report Number: 3004209178-2014-02315
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2011
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2013
• Date Device Manufactured: 03/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00060 YR