FDA Adverse Event Injury Summary report: N

INGENIO

MDR report key: 3912979 · Received July 3, 2014

Report

Report Number: 2124215-2014-13473
Event Type: Injury
Date Received: July 3, 2014
Date of Event: June 20, 2014
Report Date: June 24, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 THE PATIENT IMPLANTED WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY ROOM (ER)WITH GREATER THAN TWO SECONDS OF PACING INHIBITION. IT WAS NOTED THAT RV THRESHOLD MEASUREMENTS HAD INCREASED AND THE AUTOMATIC CAPTURE (AC) FEATURE WAS OBSERVED TO BE PACING IN RETRY AT 5 VOLTS. THE PATIENT WAS PACEMAKER DEPENDENT. IT WAS NOTED THAT THRESHOLD MEASUREMENTS HAD BEEN STEADY AT AROUND 2 TO 3 VOLTS, HOWEVER, WHILE MONITORING THE PATIENT IN THE ER, LOSS OF CAPTURE (LOC) WAS OBSERVED FOR UP TO 10 SECONDS. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE APPROXIMATELY FOUR DAYS AGO AND FELL AND HIT THEIR HEAD. IT WAS UNKNOWN IF THE SYNCOPE WAS A RESULT OF THE LOC. THE DEVICE WAS PROGRAMMED TO A FIXED OUTPUT OF 5 VOLTS AT 1.0 MILLISECONDS AND NO FURTHER LOC WAS OBSERVED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
391523	INGENIO	IMPLANTABLE PULSE GENERATOR	LWP	GUIDANT CRM CLONMEL IRELAND	K173

Patients

Seq	Age	Sex	Outcome	Treatment
1	90 YR		Hospitalization\| L\| R	4087\| 1290\| K173\| 4088