FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX

MDR report key: 4831980 · Received June 10, 2015

Report

Report Number: 2649622-2015-05258
Event Type: Malfunction
Date Received: June 10, 2015
Date of Event: April 7, 2015
Report Date: April 7, 2015
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P930039
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
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: NO EVAL EXPLAIN CODE. 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, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO OVER-ROTATION. THE HELIX OF THE LEAD WAS EXTRINSICALLY COMPRESSED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED, AND DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE IS-1 CONNECTOR. THIS IS INDICATIVE OF THE CONNECTOR PIN BEING TURNED AN EXCESSIVE NUMBER OF TIMES DURING HELIX RETRACTION. THE HELIX WAS ALSO COMPRESSED INTO THE SLEEVEHEAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY EXITING THE SCREW-IN INSIDE THE PATIENT. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
378261	CAPSUREFIX	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	5568-53

Patients

Seq	Age	Sex	Outcome	Treatment
1