FDA Adverse Event Other Summary report: N

SETROX S 45

MDR report key: 2860309 · Received November 21, 2012

Report

Report Number: 1028232-2012-02822
Event Type: Other
Date Received: November 21, 2012
Date of Event: April 1, 2011
Report Date: September 15, 2011
Manufacturer: BIOTRONIK SE AND CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

PLEASE NOTE THAT THE EVALUATION CODES AND MANUFACTURE DATE WILL BE PROVIDED IN A FOLLOW-UP REPORT. UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

Description of Event or Problem · 1

THIS DEVICE WAS RETURNED WITHOUT (B)(4) DOCUMENTATION. (B)(4) HAVE NO RECORD OF THIS PATIENT. THE FOLLOWING PHYSICIAN'S OFFICE HAS NOT SEEN THIS PATIENT IN OVER 2 YEARS. THE DATE OF EXPLANT IS UNKNOWN. ON (B)(4) 2012- ADDITIONAL INFORMATION WAS RECEIVED THAT HIS PACEMAKER AND LEAD WERE EXPLANTED ON (B)(6) 2011 AND REPLACED WITH A COMPETITOR'S DEVICE. THERE WAS NO INDICATION THAT THE ATRIAL LEAD WAS REPLACED AND BSC DID NOT HAVE A REASON FOR EXPLANT. AT THIS TIME, IT WAS DETERMINED THIS EVENT IS REPORTABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SETROX S 45	PACER LEAD	NVZ	BIOTRONIK SE AND CO. KG	350973

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Hospitalization