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

Model Number DTBA1D1

Device Problems High impedance (1291); Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-45, lead, implanted: (b)(6) 2002, 1559-65, lead, implanted: (b)(6) 2001.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that high, out-of-range defibrillation coil impedance was noted on the right ventricular (rv) lead post-generator replacement.Initially, all electrical measurements were within the normal range.The physician determined that the rv coil connector pin was probably not well-seated in the cardiac resynchronization therapy defibrillator (crt-d) header.The patient was scheduled for a procedure to reinsert the lead into the device header.Inconsistent impedance was pre-operatively noted.Both normal and out-of-range impedance was observed.It was ultimately decided to leave the lead as is and disable defibrillation therapy.The device and lead remain in use.No patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ XT CRT-D
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13872472
• MDR Text Key: 290188161
• Report Number: 3004209178-2022-03673
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530140
• UDI-Public: 00643169530140
• 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
• Type of Report: Initial
• Report Date: 03/23/2022

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: 03/28/2018
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/24/2022
• Date Device Manufactured: 10/12/2016
• 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: 4965-50 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG