MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SECURA DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number D224DRG

Device Problems Incorrect Measurement (1383); Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293); Output Problem (3005)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patients right ventricular (rv) lead exhibited high and unstable thresholds along with oversensing.Due to the oversensing the implantable cardioverter defibrillator (icd) mis-detected ventricular fibrillation (vf) which resulted in the patient receiving multiple inappropriate therapies.It was also noted that ventricular (v) marker channels did not line up with r-waves on ventricular electrogram (vegm).Additionally, the device diagnostics indicated that the patient¿s heartrate was 500 bpm when the actual rate was 75 bpm.Reprogramming has been completed and both the lead and device remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was returned and analyzed.During the analysis of the returned device the failure on the hybrid disappeared.Hybrid analysis confirmed the reported rv oversensing condition.However, a device power on reset cleared the error preventing further analysis.Other than the initially observed oversensing, the device functioned nominally with regards to the regulated supplies, reference voltages, telemetry b/c, pacing outputs, lead impedances, and device current drains.No hybrid anomalies were observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SECURA DR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 7643650
• MDR Text Key: 112544031
• Report Number: 3004209178-2018-14507
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00613994446633
• UDI-Public: 00613994446633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2012
• Device Model Number: D224DRG
• Device Catalogue Number: D224DRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2011
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR