FDA Adverse Event Injury Summary report: N

ATTAIN OTW

MDR report key: 2050602 · Received April 12, 2011

Report

Report Number: 2649622-2011-05385
Event Type: Injury
Date Received: April 12, 2011
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P010015/S012
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: HEALTH PROFESSIONAL

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.

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 DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR LESS THAN TWO YEARS AFTER IMPLANT. IT WAS NOTED THE LEFT VENTRICULAR LEAD SHOWED HIGH OUTPUTS AND WAS REPROGRAMMED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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	83 YR		Hospitalization\| R	6947 IMPLANTABLE TACHY LEAD\| 5568 IMPLANTABLE PACING LEAD\| 6947 IMPLANTABLE TACHY LEAD\| 5568 IMPLANTABLE PACING LEAD