FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2864096 · Received December 10, 2012

Report

Report Number: 3004209178-2012-11356
Event Type: Injury
Date Received: December 10, 2012
Report Date: November 7, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID, 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A POSSIBLE INFECTION AT THE PATIENT'S LUMBAR INCISION SITE. THE PATIENT PRESENTED WITH ERYTHEMA WITH SMALL AMOUNT OF DRAINAGE AT LUMBAR INCISION SITE ON (B)(6) 2012, AND SMALL DEHISCENCE OF THE LOWER PORTION AS OF (B)(6) 2012. THE PATIENT STARTED CLINDAMYCIN ANTIBIOTICS AS OF (B)(6) 2012 FOR A 14 DAY REGIMEN, AND WET TO DRY DRESSINGS TWICE A DAY FOR 8 WEEKS, STARTING ON (B)(6) 2012. AS OF (B)(6) 2012, IT WAS NOTED THAT WOUND STILL WAS NOT APPROXIMATED WELL, SO WET TO DRY DRESSINGS WERE CONTINUED. AS OF (B)(6) 2012, THERE WAS A SMALL SCAB AND AS OF (B)(6) 2012 THERE WAS A VERY SMALL AREA NOTED AS ALMOST CLOSED. THE WET TO DRY DRESSING ORDER STOOD THRU THAT TIME. IT WAS LATER REPORTED, THERE WAS A CONFIRMED INFECTION. THE SEVERITY OF THE EVENT WAS REPORTED AS MILD. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2012. THE MEDICATION IN THE PUMP WAS MORPHINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00057 YR		Required Intervention