SENSIA DR

Report

Report Number: 6000094-2010-01438
Event Type: Injury
Date Received: August 10, 2010
Date of Event: December 2, 2009
Manufacturer: MEDTRONIC S.A.
Product Code: NVZ
PMA / PMN Number: P980035/S043
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. IT SHOWED A MEASUREMENT SYSTEM LOCK-UP, RESULTING IN AN UNCLEARABLE ERI (ELECTIVE REPLACEMENT INDICATOR). A SINGLE UNIT WAS REPAIRED BUT NO OTHER DEVICES WERE REPAIRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING INTERROGATION OF THE DEVICE, THE DEVICE APPEARED TO HAVE REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE HAD "FROZEN" AT VVI AT 65PPM. THE BATTERY VOLTAGE AND IMPEDANCE COULD NOT BE MEASURED. A CUSTOM SOFTWARE DOWNLOAD WAS SUCCESSFUL IN CORRECTING THE ISSUE. THE DEVICE WAS REPROGRAMMED TO THE PATIENT'S INITIAL MODE AND ALL TESTING PERFORMED. ATRIAL LEAD THRESHOLDS WERE HIGH AND COULD NOT BE MEASURED, AND THERE WAS INTERMITTENT CAPTURE IN BOTH POLARITIES. THE ATRIAL CAPTURE MANAGEMENT TREND REPORT INDICATED THE ATRIAL LEAD THRESHOLDS HAD BEEN CONSISTENTLY HIGH. FURTHER REPROGRAMMING WAS DONE, AND THE DEVICE AND LEAD REMAIN 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	SENSIA DR	IMPLANTABLE PULSE GENERATOR	NVZ	MEDTRONIC S.A.	SEDRL1	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	4074 IMPLANTABLE PACING LEAD