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 Premature Discharge of Battery (1057); Output above Specifications (1432)

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

Event Date 04/30/2014

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.

Event Description

It was reported that the device is suspected of premature eri (elective replacement indicator).It was noted that high left ventricular (lv) lead thresholds is a known condition.The device was explanted and replaced.The lead remains in use.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 medical products: 429688, lead implanted: (b)(6) 2011; 694765, lead implanted: (b)(6) 2008; 5076-52, lead implanted: (b)(6) 2008.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 3989908
• MDR Text Key: 12383178
• Report Number: 3004209178-2014-14526
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2014

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: 04/28/2013
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/07/2014
• Supplement Dates Manufacturer Received: Not provided; 07/23/2014
• Supplement Dates FDA Received: 10/10/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2011
• 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: 407658 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00085 YR
• Patient Weight: 70