FDA Adverse Event Injury Summary report: N

LINOX TD 65/16

MDR report key: 1912661 · Received November 24, 2010

Report

Report Number: 1028232-2010-02581
Event Type: Injury
Date Received: November 24, 2010
Date of Event: November 11, 2010
Report Date: November 11, 2010
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: LWS
PMA / PMN Number: P9980023
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

Description of Event or Problem · 1

DEVICE SHOWS SEVERAL ABORTED AND DELIVERED SHOCKS FOR NOISE ON THE RV LEAD. PACE/SENSE IMPEDANCE TREND SHOWS A SLIGHT DOWNWARD TREND. NO CHANGES IN SENSING AND THRESHOLD WERE NOTED. THE NOISE DOES NOT APPEAR TO BE EXTERNAL, BECAUSE IT IS ONLY ON THE RV LEAD. MANIPULATIVE TESTING DID NOT REPLICATE THE NOISE. THE HOLTER LIST SHOWS EPISODES AT ERRATIC TIMES ALSO INDICATING THAT THE NOISE IS MOST LIKELY NOT EXTERNAL. RECOMMENDED REPLACEMENT OF THE RV LEAD. THIS LEAD WAS CAPPED DUE TO NOISE AND INAPPROPRIATE SHOCKS ON (B)(6) 2010. THE REPRESENTATIVE BELIEVES IT IS POSSIBLE THAT THE LEAD WAS FRACTURED WHILE CHANGING OUT THE ICD ON (B)(6) 2010, BECAUSE THE NOISE AND SHOCKS STARTED AFTER THE DEVICE CHANGE OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LINOX TD 65/16	ICD LEAD	LWS	BIOTRONIK SE & CO. KG	351337

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization