FDA Adverse Event Malfunction Summary report: N

ATTAIN OTW

MDR report key: 1803002 · Received August 17, 2010

Report

Report Number: 2649622-2010-08745
Event Type: Malfunction
Date Received: August 17, 2010
Date of Event: June 30, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P010015/S012
Removal / Correction Number: ASKU
Report Source: Manufacturer report
Reporter Location: SC, 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 WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR. (B)(4) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD WAS PRESENT IN/ON THE HELIX MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR LEAD DISLODGED AND COULD NOT BE PLACED IN STABLE LOCATION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD POSITIONING DIFFICULTY; IT WAS REPOSITIONED SEVERAL TIMES AND THE STYLET COULD NOT BE ADVANCED TO THE TIP. NEITHER 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
1	ATTAIN OTW	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4194	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention