MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; AICD

Model Number VIVA XT CRT DDTBA1D1

Device Problems Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problems Cardiomyopathy (1764); Death (1802); Dementia (1808); Ventricular Tachycardia (2132)

Event Date 07/21/2018

Event Type  Death  

Event Description

Pt admitted (b)(6) 2018 with weakness.Altered mental status.Polst inplace.Suspect battery depletion.Offered temporary pacemaker and device exchange.Son honored mother's wishes for no further interventions and pt (b)(6) (died).Last device check (b)(6) 2018 and battery result was 2.8 years remaining and both pacing wires functioned.Telephone check failed to transmit about 10 days prior to admission ((b)(6) or (b)(6) 2018).New kit sent out to nursing home.On admission no battery life remaining.Pt in complete heart block with no pacemaker activity.

• Brand Name: MEDTRONIC
• Type of Device: AICD
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7762478
• MDR Text Key: 116646349
• Report Number: 7762478
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VIVA XT CRT DDTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/23/2018
• Device Age: 4 YR
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 86 YR
• Patient Weight: 67