FDA Adverse Event Injury Summary report: N

ACTIVA

MDR report key: 3491019 · Received November 27, 2013

Report

Report Number: 3004209178-2013-21565
Event Type: Injury
Date Received: November 27, 2013
Date of Event: October 23, 2013
Report Date: November 12, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # VA023L5, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # VA07GD1, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS FURTHER STATED THAT "LAST FEW INFECTIONS HAVE BEEN AT BURR HOLE SITE AS WELL AS POCKET," BUT IT WAS UNKNOWN WHAT EVENT THIS PERTAINED TO. THE INFORMATION WAS ALSO REPORTED IN MANUFACTURER'S REPORTS #3007566237-2013-03854, 3004209178-2013-20039, AND 30042091 78-2013-21568.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE BURR HOLE AND AN EXPLANT WAS A REQUIRED ACTION. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
618264	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37603

Patients

Seq	Age	Sex	Outcome	Treatment
1	00045 YR		Required Intervention