FDA Adverse Event Malfunction Summary report: N

ADAPTA DR

MDR report key: 2053270 · Received April 13, 2011

Report

Report Number: 6000144-2011-01607
Event Type: Malfunction
Date Received: April 13, 2011
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: NVZ
PMA / PMN Number: P980035/S043
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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. EVALUATION SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT ON (B)(4)-2011 A POWER ON RESET (POR) OCCURRED. RADIATION THERAPY INDICATED, WHICH IS A KNOWN RISK FOR CAUSING PORS.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS RECEIVING RADIATION THERAPY AND THE DEVICE HAD TWO POWER ON RESETS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS RECEIVING RADIATION THERAPY AND THE DEVICE HAD A POWER ON RESET. IT WAS SUBSEQUENTLY REPORTED THAT THE DEVICE EXPERIENCED ANOTHER POWER ON RESET WHILE THE PATIENT WAS STILL UNDERGOING RADIATION THERAPY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADAPTA DR	IMPLANTABLE PULSE GENERATOR	NVZ	MEDTRONIC MED REL, INC.	ADDR01	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Other	5076 X2 IMPLANTABLE PACING LEAD\| 5076 X2 IMPLANTABLE PACING LEAD