SIMILAR DEVICE NS7TBL174HS, PMA # P990025

MDR report key: 4241981 · Received November 10, 2014

Report

Report Number: 2029046-2014-00421
Event Type: Injury
Date Received: November 10, 2014
Date of Event: October 10, 2014
Report Date: October 16, 2014
Manufacturer: BIOSENSE WEBSTER, INC (IRWINDALE)
Product Code: LPB
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BWI EQUIPMENT INVOLVED: CARTO3 SN: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT 2 DAYS AFTER AN AFIB ¿ PAROXYSMAL PROCEDURE WHICH WAS OCCURRED ON (B)(6) 2014, THE PATIENT DEVELOPED PERICARDITIS AND A PERICARDIAL TAP WAS PERFORMED. DURING AND AFTER THE PROCEDURE, THE PATIENT WAS STABLE, NO ABNORMALITIES WERE NOTED ON ICE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. IT WAS STATED THAT THE PHYSICIAN COULDN'T SEE THE IMPEDANCE DROPPED BECAUSE THERE WAS IMPEDANCE NOISE ON THE CARTO 3 SYSTEM AND ON THE RECORDING SYSTEM. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE AND PATIENT CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
722660		SIMILAR DEVICE NS7TBL174HS, PMA # P990025	LPB	BIOSENSE WEBSTER, INC (IRWINDALE)	D-1184-00	UNKNOWN_NAVISTAR THR

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Hospitalization\| L\| R