FDA Adverse Event Injury Summary report: N

ATLAS PLUS HF CRT-D

MDR report key: 1830977 · Received September 10, 2010

Report

Report Number: 2017865-2010-03678
Event Type: Injury
Date Received: September 10, 2010
Date of Event: July 26, 2010
Manufacturer: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code: NIK
PMA / PMN Number: P030054
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

Additional Manufacturer Narrative · 1

THE REPORTED RESET WAS CONFIRMED IN THE LABORATORY. THE DEVICE EXHIBITED A POWER ON RESET, WHICH RESULTED FROM BATTERY DEPLETION CAUSED BY A DAMAGED LEAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS. INTERROGATION OF THE DEVICE REVEALED BACK-UP VVI (BVVI) MODE WITH NO HIGH VOLTAGE THERAPY AVAILABLE. THE DEVICE COULD NOT BE PROGRAMMED DUE TO THE HARDWARE RESET AND IT COULD NOT BE RECOVERED. THE DEVICE WAS EXPLANTED AND REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, WHEN THE DEVICE WAS FIRED ON THE BLOOD VESSEL, THE CLIP DID NOT COME OUT AND THE JAW COULD NOT BE OPENED. THE DOCTOR TRIED TO GRASP THE TRIGGER SEVERAL TIMES, BUT THE TRIGGER WAS HARD, SO THE DOCTOR STOPPED GRASPING THE TRIGGER. ANOTHER DEVICE WAS FIRED ON THE TISSUE OF BOTH SIDES AND THE TISSUE BETWEEN THE CLIPS WAS CUT TO REMOVE THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATLAS PLUS HF CRT-D	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	NIK	ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION	V-343

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Required Intervention