MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDBB1D1

Device Problems Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)

Patient Problems Distress (2329); No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

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 implantable cardioverter defibrillator (icd) inappropriately withheld therapy as the icd was withholding for svt (supra ventricular tachycardia) when the patient had a true vt (ventricular tachycardia).The icd remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was further reported from information obtained from the clinic that the patient was seen in the office and the implantable cardioverter defibrillator (icd) was reprogrammed.It was also noted that during the patient¿s office visit, the patient experience pretty severe emotional distress from receiving appropriate shocks for vt (ventricular tachycardia).The patient did not feel well in general that day, but the shock was very upsetting to the patient.The patient¿s caregiver indicated that the patient was screaming for them, terrified, and then was crying on and off throughout this office visit fearful of it occurring again.

• Brand Name: EVERA¿ XT DR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 9335079
• MDR Text Key: 166782001
• Report Number: 3004209178-2019-21984
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169018099
• UDI-Public: 00643169018099
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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: 01/28/2017
• Device Model Number: DDBB1D1
• Device Catalogue Number: DDBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/20/2019
• Date Device Manufactured: 08/13/2015
• 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: 694765 LEAD, 507652 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 81 YR