DEXTRUS 4136

Report

Report Number: 1028232-2013-01342
Event Type: Injury
Date Received: May 13, 2013
Date of Event: April 5, 2013
Report Date: May 3, 2013
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVN
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED. THE MORPHOLOGY OF THE CUTTINGS INDICATES, THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANTATION PROCEDURE. THE RETURNED DEVICE WAS VISUALLY AND ELECTRICALLY ANALYZED. THE INSPECTION SHOWED CUTTINGS IN THE INSULATION AT THE DISTAL PART OF THE FRAGMENT AS WELL AS A DEFORMED FIXATION HELIX WHICH OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENTS WERE INVESTIGATED AND PROVED TO BE FLAWLESS. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE PRE-DISCHARGE CHECK ONE DAY POST IMPLANT, THE RIGHT ATRIAL LEAD EXHIBITED POOR SENSING AND LOSS OF CAPTURE WITH ASYSTOLE OF LESS THAN TWO SECONDS. DURING THE REVISION PROCEDURE IT WAS NOTED THAT THE LEAD WAS DISLODGED AND STUCK ON A VALVE. THE PHYSICIAN WAS UNABLE TO REVISE THE LEAD, THUS IT WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO MEASUREMENTS WERE PROVIDED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
210420	DEXTRUS 4136	PACER LEAD	NVN	BIOTRONIK SE & CO. KG	358754

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization