FDA Adverse Event Injury Summary report: N

ATTAIN ABILITY

MDR report key: 1864750 · Received October 12, 2010

Report

Report Number: 2649622-2010-10956
Event Type: Injury
Date Received: October 12, 2010
Date of Event: July 30, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: OJX
PMA / PMN Number: P080006
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, BLOOD IN/ON HELIX /LOBE MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS ON THE CHRONICALLY IMPLANTED 5092 LEAD. DURING AN UPGRADE PROCEDURE, THE LEAD WAS CAPPED AND REPLACED WITH 5076 LEAD AFTER A DIFFERENT 5092 LEAD KEPT DISLODGING. DURING THE SAME PROCEDURE, TWO DIFFERENT LV LEADS WERE ATTEMPTED BUT NOT IMPLANTED DUE TO PATIENT ANATOMY AND/OR LEAD LENGTH BEING TOO SHORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN ABILITY	IMPLANTABLE PACING LEAD	OJX	MEDTRONIC PUERTO RICO, INC.	4196	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	92 YR		Required Intervention	SESR01 IMPLANTABLE PULSE GENERATOR