RESTORE PRIME ADVANCED

Report

• Report Number: 3004209178-2010-06069
• Event Type: Malfunction
• Date Received: August 12, 2010
• Date of Event: January 1, 2010
• Report Date: July 13, 2010
• Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
• Product Code: LGW
• PMA / PMN Number: P840001
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: NY, US
• Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT HAD LOST A LOT OF WEIGHT AND THE POCKET SIZE HAD CHANGED, SO THE DEVICE WAS MOVING AROUND. WHEN THE PT TURNED OVER IN BED; THEIR DEVICE ALMOST FLIPS IN THE POCKET AND MUST BE HELD IN PLACE. THE PT WAS AT HOME IN AN UNDETERMINED CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE PRIME ADVANCED		LGW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	37702	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR			EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE143100N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA110106N| LEAD: MODEL 3777, LOT # V082195027| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT # V082195028| EXPLANTED:| IMPLANTED:| IMPLANTED:

Terms

Patient problem · 1

• Discomfort

Product problems · 1

• Device Tipped Over

Source type · 1

• Consumer

Type of report · 1

• Initial submission