FDA Adverse Event Malfunction Summary report: N

SPRINT

MDR report key: 1925921 · Received December 14, 2010

Report

Report Number: 2649622-2010-14101
Event Type: Malfunction
Date Received: December 14, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S13
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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THE PRESENCE OF OVERSENSING. THERE WERE NINE VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES WITH LESS THAN 200 MS AVERAGE VENTRICULAR CYCLE LENGTH RECORDED BETWEEN (B)(6) 2010 AND (B)(6) 2010. ANALYSIS ALSO NOTED INTERFERENCE/NOISE WAS RECORDED. THE VENTRICULAR SHORT INTERVAL COUNT AVERAGED 2977.5 COUNTS/DAY, OVER 35 DAYS, BETWEEN (B)(6) 2010 AND (B)(6) 2010.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE SHOWS A HIGH NUMBER OF SHORT INTERVAL COUNTS AND OVERSENSING WAS NOTED. THE DEVICE 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	SPRINT	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6943	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Other	(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| 5568 IMPLANTABLE PACING LEAD\| 5568 IMPLANTABLE PACING LEAD