CRYSTALLINE

Report

Report Number: 2649622-2010-10075
Event Type: Injury
Date Received: October 8, 2010
Date of Event: July 5, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S017
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

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 ROOT CAUSE OF THE CONFIRMED EGM NOISE COULD NOT BE DETERMINED. ANALYSIS FOUND A CRACKED INTEGRATED CIRCUIT ON THE HYBRID. IT COULD NOT BE DETERMINED WHEN THE CRACK OCCURRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR ELECTROGRAMS SHOWED ELECTROMAGNETIC INTERFERENCE WHILE THE PACEMAKER PERFORMED APPROPRIATE SENSING WITH NO OVERSENSING. THE SURFACE ELECTROGRAM DID NOT SHOW ELECTROMAGNETIC INTERFENENCE, SO THE PHYSICIAN DID NOT BELIEVE THE SOURCE OF THE INTERFERENCE WAS FROM AN OUTSIDE SOURCE. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS ARE STILL 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	CRYSTALLINE	ASKU	DTB	MEDTRONIC PUERTO RICO, INC.	ICQ09B	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Hospitalization\| R