FDA Adverse Event Malfunction Summary report: N

ATTAIN ABILITY

MDR report key: 2123556 · Received June 14, 2011

Report

Report Number: 2649622-2011-08142
Event Type: Malfunction
Date Received: June 14, 2011
Date of Event: March 4, 2011
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: OJX
PMA / PMN Number: P080006
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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) THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). IT WAS NOTED THAT GUIDEWIRE STUCK IN LEAD AND THE LEAD APPEARED DAMAGE AT IMPLANT. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT AFTER MULTIPLE PLACEMENT ATTEMPTS THE STYLET GOT STUCK AND THERE WAS BLOOD IN THE LUMEN. UNSUCCESSFUL ATTEMPTS WERE MADE WITH THREE ADDITIONAL LEADS. THE FIRST WAS OPENED AND NOT USED BECAUSE IT WAS "CONTAMINATED ON FIELD". THE SECOND WAS NOT IMPLANTED DUE TO PATIENT ANATOMY, AND THE THIRD WAS AN INNAPROPRIATE LENGTH. AN EPICARDIAL LEFT VENTRICULAR LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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	85 YR		Other