DEXTRUS 4137

Report

Report Number: 1028232-2014-002370
Event Type: Malfunction
Date Received: July 14, 2014
Date of Event: May 26, 2014
Report Date: July 2, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCES OF GREATER THAN 2,000 OHMS AND HIGH PACING THRESHOLD MEASUREMENTS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE LEAD HAD A CRUSHED SUTURE SLEEVE WHICH WAS CONCLUSIVELY DETERMINED THROUGH FLUOROSCOPY. THE LEAD IMPEDANCE WAS TESTED WITH THE PACEMAKER AND GOT AN OUT OF RANGE MEASUREMENT OF 2,430 OHMS. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW ONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
410960	DEXTRUS 4137	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358764

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization