FDA Adverse Event Injury Summary report: N

LINOX SMART S DX 65/17

MDR report key: 3984481 · Received August 6, 2014

Report

Report Number: 1028232-2014-002764
Event Type: Injury
Date Received: August 6, 2014
Date of Event: July 21, 2014
Report Date: July 23, 2014
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVY
PMA / PMN Number: P980023
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

AN INFECTION WAS OBSERVED FOLLOWING THE IMPLANTATION OF THIS BIOTRONIK DEVICE. THE STERILIZATION PROCESS WAS INVESTIGATED. THE VALIDATED PROCESS ASSURES THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., ARE WITHIN ITS SPECIFIED RANGES FOR EACH DISTRIBUTED DEVICE. ADDITIONAL AN ANALYSIS OF VALIDATED MICROBIOLOGICAL INDICATORS IS PERFORMED AFTER EVERY STERILIZATION PROCEDURE AS EVIDENCE OF SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. REVIEW OF THE BIOTRONIK COMPLAINT DATABASE DID NOT REVEAL ANY CHANGES REGARDING THE TREND FOR THIS TYPE OF INCIDENT. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

Description of Event or Problem · 1

THIS LEAD WAS CAPPED AND THE DEVICE WAS REMOVED DUE TO VEGETATION. THERE IS NO INDICATION THAT THE SYSTEM WAS REPLACED. THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
460203	LINOX SMART S DX 65/17	ICD LEAD	NVY	BIOTRONIK SE & CO. KG	365501

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Hospitalization