FDA Adverse Event Injury Summary report: N

ATTAIN ABILITY

MDR report key: 2964606 · Received February 15, 2013

Report

Report Number: 2649622-2013-01979
Event Type: Injury
Date Received: February 15, 2013
Report Date: December 28, 2012
Manufacturer: MPRI
Product Code: OJX
PMA / PMN Number: P080006
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 3830 IMPLANTABLE PACING LEAD (B)(6) 2010; 6935 IMPLANTABLE DEFIBRILLATOR LEAD (B)(6) 2010. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED FOR HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT THE RV LEAD HAD VARIABLE IMPEDANCE, INCREASED PACING THRESHOLD, NOISE IN THE BIPOLAR CONFIGURATION AND WAS UNABLE TO CAPTURE. THE PHYSICIAN COULD NOT DETERMINE IF THE ISSUES WERE FROM THE RV LEAD OR DUE TO A HEADER PROBLEM WITH THE DEVICE. BOTH THE RV LEAD AND THE DEVICE WERE EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN REPOSITIONED SEVERAL WEEKS POST-IMPLANT. DURING THIS PROCEDURE, THE LV LEAD WAS PARTIALLY EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
67118	ATTAIN ABILITY	DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE	OJX	MPRI	419678

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	D224TRK IMPLANTABLE CARDIAC DEFIBRILLATOR