INSYNC SENTRY

Report

Report Number: 6000094-2010-01373
Event Type: Injury
Date Received: June 11, 2010
Date of Event: January 29, 2010
Manufacturer: MEDTRONIC S.A.
Product Code: NIK
PMA / PMN Number: ASKU
Removal / Correction Number: ASKU
Product Problem: Yes
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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

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. DEVICE MODEL 7298 IS NOT APPROVED IN THE US; HOWEVER IT IS SIMILAR TO US DEVICES APPROVED UNDER PMA: P1010031.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BATTERY OF THE DEVICE DEPLETED BEFORE EXPECTED TIME (LESS THAN 3 YEARS). THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BATTERY OF THE DEVICE DEPLETED BEFORE EXPECTED TIME (LESS THAN 3 YEARS). THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INSYNC SENTRY	ASKU	NIK	MEDTRONIC S.A.	7298	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention