FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3252520 · Received July 29, 2013

Report

Report Number: 3004209178-2013-12415
Event Type: Injury
Date Received: July 29, 2013
Report Date: July 2, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD AN INCISION INFECTION AT THE PUMP POCKET. THE PATIENT WAS SCHEDULED FOR INCISION AND DRAINAGE (IND) WASHOUT ON (B)(6) 2013 WITH POSSIBLE REMOVAL OF THE ENTIRE SYSTEM. ANOTHER UPDATE ON THE EVENT WAS PLANNED FOLLOWING THE IND WASHOUT, SURGICAL INTERVENTION COMPLETION. THE EVENT WAS DIAGNOSED BY AN ELEVATED ERYTHROCYTE SEDIMENTATION RATE (SED. RATE) AND C-REACTIVE PROTEIN (CRP) ON (B)(6) 2013. THE INCISION WAS NOTED TO BE DEHISCED AND LEAKING FLUID IN A 1 CM AREA. THE EVENT WAS ONGOING. THE PUMP DEVICE WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE ENTIRE SYSTEM WAS EXPLANTED AT THE TIME OF IND WASHOUT, ON (B)(6) 2013. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352860	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00009 YR		Required Intervention