FDA Adverse Event Injury Summary report: N

DEXTRUS 4135

MDR report key: 1952055 · Received January 3, 2011

Report

Report Number: 1028232-2010-02883
Event Type: Injury
Date Received: January 3, 2011
Date of Event: November 23, 2010
Report Date: December 22, 2010
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

OUS MDR - 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

OUS MDR - BIOTRONIK RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, IT WAS NOTED THIS LEAD HAD LOSS OF CAPTURE. A REVISION PROCEDURE WAS PERFORMED. PRIOR TO THE REPOSITION, IT WAS NOTED THERE WAS A CARDIAC TAMPONADE REQUIRING A PERICARDIAL DRAIN. ONCE THE PATIENT WAS STABILIZED, THE LEAD WAS REPOSITIONED SUCCESSFULLY. POST IMPLANT, THE PATIENT WAS STABLE AND NORMAL MEASUREMENTS WERE OBTAINED. NO FURTHER ADVERSE PATIENT SYMPTOMS WERE REPORTED. ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEXTRUS 4135	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	360303

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization