FDA Adverse Event Injury Summary report: N

ENERGEN

MDR report key: 2910876 · Received January 11, 2013

Report

Report Number: 2124215-2012-16098
Event Type: Injury
Date Received: January 11, 2013
Date of Event: October 30, 2012
Report Date: November 13, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE EVALUATION IT WAS DISCOVERED THAT 2 NON-SUSTAINED EPISODES OCCURED SOMETIME IN THE MONTH OF (B)(6) THAT WERE CAUSED FROM NOISE SENSED ON THE RIGHT VENTRICULAR (RV) RATE/SENSE LEAD. THE SHOCKING WAS NORMAL. THERE WAS NO EVIDENCE OF PACING INHIBITION OR ASYSTOLE AS THE PATIENT HAD AN UNDERLYING RHYTHM OF 58 BEATS PER MINUTE (BPM) DURING THIS TIME. THE FIELD REPRESENTATIVE PERFORMED ISOMETRICS, HOWEVER, NOT AGGRESSIVELY DO TO THE COMFORT LEVEL OF THE PATIENT WHILE MOVING THEIR ARM. NO NOISE WAS ABLE TO BE REPRODUCED ON THE RV RATE/SENS BUT A VERY SMALL AMOUNT OF NOISE ON THE SHOCK PORTION OF THE LEAD. ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE PATIENT WAS BROUGHT IN FOR FURTHER EVALUATION, AT WHICH TIME NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
16871	ENERGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E141

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Life Threatening	T177\| 6949\| 0185\| E141\| 0184