SWEET TIP

Report

Report Number: 2124215-2013-06979
Event Type: Malfunction
Date Received: July 8, 2013
Date of Event: April 15, 2013
Report Date: April 15, 2013
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
PMA / PMN Number: P960006
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT OF THE IMPLANTED DEVICE AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HEADER WAS EXAMINED. VISUAL INSPECTION NOTED A LEAD TIP IN THE VENTRICULAR PORT, HOWEVER, WAS UNABLE TO CONFIRM THE MODEL/SERIAL INFORMATION. PLEASE REFERENCE REPORT 2124215-2013-06980.

Additional Manufacturer Narrative · 1

ANOTHER MANUFACTURER'S DEVICE AND RV LEAD WERE SUCCESSFULLY IMPLANTED. A PORTION OF THE LEAD IS EXPECTED TO BE RETURNED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

Description of Event or Problem · 1

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Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ROUTINE REPLACEMENT OF THIS PACEMAKER, THE RIGHT VENTRICULAR SET SCREWS WERE UNABLE TO BE LOOSENED AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM THE HEADER. WHILE THE LEAD WAS BEING PULLED FROM THE HEADER, THE INSULATION PULLED BACK AND THE LEAD CONDUCTOR BECAME FRACTURED. THE LEAD WAS CUT AND SURGICALLY ABANDONED, HOWEVER, A PORTION REMAINED IN THE HEADER. TROUBLESHOOTING WAS PERFORMED AND THE SET SCREWS WERE ABLE TO BE LOOSENED AND THE REMAINING PORTION OF THE LEAD WAS REMOVED FROM THE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309197	SWEET TIP	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4245

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR			1276\| 5534\| 1274\| 1174\| 4244\| K173\| 4245\| 4076