FDA Adverse Event Injury Summary report: N

SIGMA 300 D

MDR report key: 1803280 · Received August 17, 2010

Report

Report Number: 2647346-2010-00477
Event Type: Injury
Date Received: August 17, 2010
Date of Event: November 2, 2009
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: DXY
PMA / PMN Number: P980035/S2
Removal / Correction Number: Z-1510/1519-2009
Report Source: Manufacturer report
Reporter Location: TW
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT WHEN DEVICE WAS PROGRAMMED DDD 60 BPM BIPOLAR MODE. TESTING ON THE AUTOMATED FUNCTIONAL TESTERS REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCE MEASURED OPEN ON (B)(6) 2009 WHICH IS BEFORE THE EXPLANT DATE OF (B)(6) 2009. ANALYSIS OF THE MEMORY DUMP INDICATED THAT THE WIRE BOND LIFTS OCCURRED BEFORE EXPLANT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEIVCE WAS "NON-FUNCTION" AND THE LEAD IMPEDANCE ON ATRIAL AND RIGHT VENTRICULAR LEADS WAS GREATER THAN 999 OHMS WITH NO OUTPUT. THE LEADS WERE CHECKED AND PERFORMED NORMALLY. 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
1	SIGMA 300 D	IMPLANTABLE PULSE GENERATOR	DXY	MEDTRONIC MED REL, INC.	SD303	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 YR		Required Intervention	4592 IMPLANTABLE PACING LEAD\| 4092 IMPLANTABLE PACING LEAD