SOLETRA

MDR report key: 2900482 · Received January 7, 2013

Report

Report Number: 3007566237-2013-00068
Event Type: Injury
Date Received: January 7, 2013
Report Date: December 17, 2012
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 09016-95, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION.

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS A DOCUMENTARY ABOUT A PATIENT WITH TOURETTE SYNDROME THAT WAS IMPLANTED WITH A DEEP BRAIN STIMULATION IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THE INS "DID NOT WORK". NO SYMPTOMS OR INJURIES WERE REPORTED IN RELATION TO THIS EVENT. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WOULD CONTACT THE HEALTHCARE PROVIDER FOR MORE INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE OF THE PATIENT'S EXTENSIONS WAS REPLACED ON (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT OUTCOME WAS "OK." SEE MFR REPORT # 3007566237-2012-01683.

Description of Event or Problem · 1

ADDITIONAL INFORMATION INDICATED THE DOCUMENTARY WAS "ALREADY 3 YEARS OLD." PATIENT OUTCOME WAS REPORTED AS "OK AND RECEIVING THERAPY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
7171	SOLETRA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION	7426

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention