MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Bone Fracture(s) (1870); Hematoma (1884); Hypoxia (1918); Unspecified Infection (1930); Laceration(s) (1946); Myocardial Infarction (1969); Pain (1994); Brain Injury (2219)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076 x2 leads, implanted: (b)(6) 2001.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by an attorney that the patient was "taken off the defibrillator without monitoring" and then experienced a "heart attack" and "brain damage due to lack of oxygen." it was clarified through follow-up that the patient was in the hospital for a cardiac resynchronization therapy defibrillator (crt-d) system explant procedure with laser lead extraction due to an infection.The health care professionals and medical equipment company representative discussed the procedure, noted the patient was not dependent and there had been no therapy nor shocks from the device, so the device was deactivated for the procedure.It was later reported by an attorney that prior to the device extraction due to infection, "antibiotic treatments and a pocket exploration" were performed.It was also reported by an attorney that the "biv-icd was disabled and (the patient was) without continuous cardiac monitoring" and consequently, the patient experienced "ventricular fibrillation cardiac arrest for "longer than 18 minutes." then "his biv-icd was reactivated, he was intubated, induced into a coma, and placed on hypothermia protocols in hopes of reducing the effects of.Anoxic brain injury." next, the patient was extubated, weaned off hypothermia protocols, and regained consciousness where "it became obvious that he suffered from confusion, short term memory loss, decreased ability to express himself, inability to follow complex commands, inability to comprehend where he was and why he was there, anger, agitation and a myriad of other deficiencies, all of which were attributable to the cerebral hypoxia event that occurred during his ventricular fibrillation cardiac arrest." the attorney also alleged the patient was in "excruciating pain" requiring medication, and suffered pain from fractured ribs due to resuscitation.It was also noted the patient had a catheterization lab procedure, a laceration of the external iliac artery, hematoma, acute blood loss anemia, iliac artery repair, and hematoma evacuation - all of which were resultant from "ventricular fibrillation cardiac arrest." to treat the infection, the attorney noted debridement of the pocket, a temporary pacing system, and a "wound vac", the a new crt-d system was implanted.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7458284
• MDR Text Key: 106430046
• Report Number: 3004209178-2018-08816
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007246
• UDI-Public: 00643169007246
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2016
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Date Device Manufactured: 11/25/2014
• 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: 4196 LEAD, 6947 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR