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

Model Number D314TRG

Device Problems Mechanical Problem (1384); Impedance Problem (2950)

Patient Problems Edema (1820); Hematoma (1884); Hernia (2240)

Event Date 01/02/2014

Event Type  Injury  

Event Description

It was reported by the patient¿s caregiver that the patient has gone through four procedures she feels are related to the patient¿s device¿a hernia, blood pool in the pocket, two loose leads, and edema in the feet.Follow-up information from the company representatives indicates that one week after a device change there was a lead alert and upon interrogation the right ventricular (rv) lead resistance was up.During revision it was found that the set screws on the device were not holding the lead properly and the lead kept slipping out of the header.The device was explanted and replaced, and all numbers were within normal limits.Two weeks later there was another alert and the patient underwent a revision for the rv lead.The lead was capped and replaced by a chronic pace/sense lead.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the rv impedance was high.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: 5076 implantable pacing lead, (b)(6) 2007; 4195 implantable pacing lead, (b)(6) 2009.(b)(4).

Manufacturer Narrative

Add'l device info: corrected from (b)(4) to (b)(4), explant date: corrected from 2014 (b)(6) to 2014 (b)(6).Product event summary: the device was returned, analyzed and no anomalies were found.(b)(4).

• Brand Name: PROTECTA XT 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: 3742539
• MDR Text Key: 4221888
• Report Number: 3004209178-2014-06745
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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
• Treatment: 6944-65 IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00091 YR