FDA Adverse Event Injury Summary report: N

PRIMEADVANCED

MDR report key: 2624638 · Received June 21, 2012

Report

Report Number: 3004209178-2012-04710
Event Type: Injury
Date Received: June 21, 2012
Report Date: May 24, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-33, LOT # V871804, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3093-33, LOT # V871804, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012; PRODUCT TYPE LEAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED DUE TO A (B)(6) INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REMOVED THREE DAYS AFTER IMPLANT. SIGNS AND SYMPTOMS OF THE INFECTION INCLUDED REDNESS, DRAINAGE, AND INCISIONAL WOUND OPENING. THE LOCATION OF THE INFECTION WAS AT THE POCKET SITE. A CULTURE WAS OBTAINED AND IT WAS (B)(6), THE PATIENT WAS A KNOWN CARRIER. THE PATIENT WAS GIVEN AN IV AND ORAL ANTIBIOTICS FOR THE INFECTION. A TOTAL DEVICE SYSTEM EXPLANT WAS PERFORMED. IT WAS NOTED THE PATIENT HAD RISK FACTORS BEFORE THE IMPLANT THAT WERE A POST-OP WOUND OR SKIN CONTAMINATION. THE INFECTION RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRIMEADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MDT PUERTO RICO OPERATIONS CO	37702

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention