KINETRA

MDR report key: 1627216 · Received March 2, 2010

Report

Report Number: 3004209178-2010-01631
Event Type: Malfunction
Date Received: March 2, 2010
Date of Event: February 3, 2010
Report Date: February 3, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
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

SEE MANUFACTURER # 6000032-2010-01632. THE PT EXPERIENCED A RETURN OF SHAKING WHEN HE TURNED THE TV ON AND OFF. THERE WAS A PROBLEM WITH THE PT PROGRAMMER. HE WAS UNABLE TO ADJUST STIMULATION. THE NEUROSTIMULATOR BATTERY INDICATOR LIGHT WOULD NOT LIGHT UP. IT WAS VERIFIED THAT THE BATTERY WAS GOOD. ADD'L INFO HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KINETRA		MHY	MDT PUERTO RICO OPERATIONS CO., JUNCOS	7428	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR			IMPLANTED:\| EXTPLANTED:\| EXTENSION: MODEL 7482, LOT # NGK018610N\| LEAD: MODEL 3387, LOT # J0230891V\| LOT # NFW113444H\| IMPLANTED:\| EXPLANTED:\| IMPLANTABLE NEURO STIMULATOR: MODEL 7426\| EXPLANTED:\| IMPLANTED:\| PROGRAMMER: MODEL PROGRAMMER, LOT # UNK\| EXPLANTED:\| IMPLANTED:\| IMPLANTED:\| EXPLANTED:\| EXTENSION: MODEL 7482, LOT # NGK015913N\| LEAD: MODEL 3387, LOT # J0230891V