FDA Adverse Event Malfunction Summary report: N

ASKU

MDR report key: 1921421 · Received December 13, 2010

Report

Report Number: 2182208-2010-00928
Event Type: Malfunction
Date Received: December 13, 2010
Manufacturer: MEDTRONIC, INC.
Product Code: DTB
PMA / PMN Number: ASKU
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR LEAD PACE/SENSE IMPEDANCE WAS HIGH, AND REMAINED SO, DESPITE MULTIPLE DEVICE PORT RECONNECTION ATTEMPTS. FOLLOW-UP ATTEMPTS HAVE YIELDED NO ADDITIONAL INFORMATION FOR THIS EVENT. THE DEVICE WAS NOT USED, AND REPLACED WITH A NEW DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASKU	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC, INC.	LEAD/MEDT	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other