FDA Adverse Event Injury Summary report: N

RESTORE SENSOR

MDR report key: 2863081 · Received December 10, 2012

Report

Report Number: 3004209178-2012-11282
Event Type: Injury
Date Received: December 10, 2012
Report Date: November 12, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND EXPLANT OCCURRED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, REPORTED THAT THE INFECTION ONSET WAS ON (B)(6) 2012. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE INFECTION WAS IN THE LUMBAR REGION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE WHOLE DEVICE SYSTEM WAS EXPLANTED. THE INFECTION RESOLVED AND THE HEALTH CARE PROFESSIONAL (HCP) WAS "STILL FOLLOWING THE PATIENT." IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS RISK FACTORS, BEFORE IMPLANTATION OF THE DEVICE, OF DIABETES AND A DEBILITATED STATUS. IT WAS UNCLEAR IF DIABETES WAS CHECKED OR NOT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE SENSOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37714

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention