MEDTRONIC.SIGMA

Report

Report Number: 9614453-2013-00250
Event Type: Injury
Date Received: February 9, 2013
Date of Event: December 4, 2012
Report Date: April 2, 2013
Manufacturer: IPG MFG SWITZERLAND
Product Code: NVZ
PMA / PMN Number: P980035
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: 4092 IMPLANTABLE PACING LEAD: (B)(6) 2002. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE HAD REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE DEVICE EXHIBITED SEVERAL THREE TO SIX SECOND PAUSES, POSSIBLY AS A RESULT OF OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE HAD REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE DEVICE EXHIBITED SEVERAL THREE TO SIX SECOND PAUSES, POSSIBLY AS A RESULT OF OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
55714	MEDTRONIC.SIGMA	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	IPG MFG SWITZERLAND	SDR303

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	5076 IMPLANTABLE PACING LEAD