THERA-I SR

Report

Report Number: 2647346-2010-00286
Event Type: Injury
Date Received: June 10, 2010
Date of Event: April 27, 2010
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: DXY
PMA / PMN Number: P890003/S37
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, 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.

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 IN A NO OUTPUT AND NO TELEMETRY STATE. THE NO OUTPUT AND NO TELEMETRY CONDITION WAS THE RESULT OF BATTERY DEPLETION. LONGEVITY TESTING AT NOMINAL SETTINGS REVEALED THE DEVICE HAD MET ITS EXPECTED LONGEVITY.

Description of Event or Problem · 1

REPORT RECEIVED INDICATED THAT THERE IS NO MAGNET RESPONSE WITH DONUT MAGNET. IN ADDITION THERE IS INABILITY TO ESTABLISH TELEMETRY. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

REPORT RECEIVED INDICATED THAT THERE IS NO MAGNET RESPONSE WITH DONUT MAGNET. IN ADDITION THERE IS INABILITY TO ESTABLISH TELEMETRY. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THERA-I SR	IMPLANTABLE PULSE GENERATOR	DXY	MEDTRONIC MED REL, INC.	8960IB	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Required Intervention	4024 IMPLANTABLE PACING LEAD