FDA Adverse Event Injury Summary report: N

ACTIVA

MDR report key: 4334223 · Received December 16, 2014

Report

Report Number: 3004209178-2014-24058
Event Type: Injury
Date Received: December 16, 2014
Report Date: November 24, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MRU
PMA / PMN Number: H020007
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 64001, LOT# N251181, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387-40, LOT# J0214131V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD; PRODUCT ID 7495LZ66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION; PRODUCT ID 64001, LOT# N251185, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT HAD ONE INSTANCE OF A STAPH INFECTION AND HAD TO HAVE THEIR IMPLANTABLE NEUROSTIMULATORS (INS) REMOVED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. PLEASE SEE MANUFACTURER REPORT #3004209178-2014-24056 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
824520	ACTIVA	IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)	MRU	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37612

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention