FDA Adverse Event Injury Summary report: N

PATCH

MDR report key: 2910659 · Received January 11, 2013

Report

Report Number: 2124215-2012-16514
Event Type: Injury
Date Received: January 11, 2013
Date of Event: November 16, 2012
Report Date: November 16, 2012
Manufacturer: HISTORICAL PUERTO RICO
Product Code: NHW
PMA / PMN Number: P830060
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE LEADS REMAIN IMPLANTED AND SURGICALLY ABANDONED. 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 OUT OF RANGE SHOCK IMPEDANCES GREATER THAN 125 OHMS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THIS WAS NOTED FOLLOWING THE RECENT DEVICE CHANGE OUT THAT OCCURRED IN THE PREVIOUS MONTH. THIS PATIENT HAS AN ABDOMINAL SYSTEM. THE CONCERN WAS THAT THIS MAY BE THE CAUSE OF THE OUT OF RANGE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PERFORMING FURTHER TESTING OR TO PERFORM A SAVE TO DISC FOR FURTHER INFORMATION. SUBSEQUENTLY ADDITIONAL INFORMATION WAS RECEIVED THAT FOUR DAYS FOLLOWING THIS REPORT, THIS SYSTEM WAS PART OF A REVISION DUE TO AN INFECTION. NO ADDITIONAL TESTING OR FOLLOW-UP WAS PERFORMED BECAUSE OF THE INFECTION. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE EFFECTS RELATED TO THE OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEADS WERE ABANDONED AND REMAIN IMPLANTED. THE DEVICE WILL BE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17778	PATCH	IMPLANTABLE LEAD	NHW	HISTORICAL PUERTO RICO	0041

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Hospitalization\| L\| R	1857\| 1746\| 6162\| 6931\| 4320\| E141\| 0041\| 1600\| 0010