FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX MRI SURESCAN

MDR report key: 3863225 · Received June 10, 2014

Report

Report Number: 3008973940-2014-00196
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: April 7, 2014
Report Date: April 7, 2014
Manufacturer: MEDTRONIC SINGAPORE OPERATIONS
Product Code: NVN
PMA / PMN Number: P090013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Additional Manufacturer Narrative · 1

CORRECTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED; ANALYSIS REVEALED THE HELIX WAS BENT. VISUAL ANALYSIS NOTED THE LEAD WAS DAMAGED AT IMPLANT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD WAS "CAUGHT IN SOMETHING AROUND THE SUPERIOR VENA CAVA (SVC)" AND GOT STUCK. THE PHYSICIAN ADVANCED AND RETRACTED THE HELIX A FEW TIMES AND NOTED THE HELIX WAS BENDING. THE PHYSICIAN ROTATED THE LEAD ITSELF AND WAS ABLE TO REMOVE THE LEAD. THE LEAD HELIX WAS EXERCISED OUTSIDE OF THE PATIENT AND RETRACTED APPROPRIATELY, HOWEVER THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
341027	CAPSUREFIX MRI SURESCAN	DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE	NVN	MEDTRONIC SINGAPORE OPERATIONS	5086MRI58

Patients

Seq	Age	Sex	Outcome	Treatment
1