FDA Adverse Event Malfunction Summary report: N

DEXTRUS 4136

MDR report key: 2903959 · Received November 29, 2012

Report

Report Number: 1028232-2012-02963
Event Type: Malfunction
Date Received: November 29, 2012
Date of Event: August 20, 2012
Report Date: November 14, 2012
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

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 - BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PRODUCT IS TO BE PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ADDITIONAL INFO RECEIVED THAT THE REVISION PROCEDURE WAS PERFORMED. THE PT'S SKIN AROUND THE DEVICE WAS THIN. THE SYSTEM WAS EXPLANTED WITH A PLASTIC SURGEON. THE PT HAD A DIFFICULT RECOVERY FROM THE WOUND DUE TO ANTICANCER DRUG OR BLOOD STANCHING. THE POCKET WAS OPENED SEVERAL TIMES TO STOP BLEEDING. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEXTRUS 4136	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	360310

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization