SELUTE PICOTIP

Report

Report Number: 2124215-2013-05489
Event Type: Injury
Date Received: April 10, 2013
Date of Event: February 15, 2013
Report Date: February 15, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P950001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

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 THE PATIENT WITH THIS PACING SYSTEM HAD A SYNCOPAL EPISODE AND FELL TO THE GROUND. THE PATIENT'S SON REPORTED THE PATIENT HAD NO PULSE AND WAS NOT BREATHING, BUT CAME TO ONCE CPR WAS STARTED. NO EPISODES OF ASYSTOLE WERE DOCUMENTED ON TELEMETRY. A DEVICE EVALUATION WAS DONE AND NOISE WITH OVERSENSING WAS PRESENT ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE RA LEAD HAD IMPEDANCES >2500 OHMS AND NO CAPTURE AS WELL. THE RV LEAD HAD IMPEDANCES FROM 160 TO 560 OHMS AND CAPTURE WAS NOTED TO BE RELATED TO THE PATIENT'S POSITION; THE LEAD IMPEDANCE WAS 700 OHMS ONE YEAR AGO. AT THE TIME OF THE CHECK, THE PATIENT WAS IN SINUS RHYTHM AND THE FIELD REPRESENTATIVE DISCUSSED PROGRAMMING OPTIONS WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS PROGRAMMED TO VVI 60 AND RV OUTPUTS WERE INCREASED AND THE LEAD SAFETY SWITCH FEATURE WAS TURNED ON. THE INFORMATION WAS REVIEWED WITH THE PATIENT'S PHYSICIANS AND THE PATIENT WILL BE FOLLOWED IN THE CLINIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE SYSTEM REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
152902	SELUTE PICOTIP	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4035

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Hospitalization\| L\| R	S606\| 4035\| 1270\| 4064