INTERSTIM II

Report

• Report Number: 3004209178-2010-07576
• Event Type: Malfunction
• Date Received: October 4, 2010
• Date of Event: September 7, 2010
• Report Date: September 7, 2010
• Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
• Product Code: EZW
• PMA / PMN Number: P970004
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: TX, US
• Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A POWER-ON-RESET (POR) CONDITION. CLEARING THE POR CONDITION WAS REVIEWED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT #3004209178201007594.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERSTIM II		EZW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	3058	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR			LEAD: MODEL 3093, LOT# V328412| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD112068N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD112070N| IMPLANTED:| LOT# NJY154063H| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,| EXPLANTED:

Terms

Patient problem · 1

• No Information

Product problems · 1

• Device Inoperable

Source type · 1

• Consumer

Type of report · 1

• Initial submission