FDA Adverse Event Injury Summary report: N

ACTIVA

MDR report key: 4657143 · Received April 3, 2015

Report

Report Number: 3004209178-2015-05931
Event Type: Injury
Date Received: April 3, 2015
Report Date: March 12, 2015
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 64002, LOT# N347789, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V030671, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V012262, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO AN INFECTION. THE PATIENT WAS LATER RE-IMPLANTED. MORE SPECIFIC DETAILS ABOUT THE INFECTION WERE UNKNOWN, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
221242	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention