FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2803212 · Received October 24, 2012

Report

Report Number: 3004209178-2012-09485
Event Type: Injury
Date Received: October 24, 2012
Report Date: September 25, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CATHETER: MODEL# 8781 SERIAL# (B)(4), IMPLANTED: (B)(6) 2012 EXPLANTED: (B)(6) 2012. (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS A MAJOR INFECTION FOLLOWING A CATHETER REPLACEMENT ON (B)(6) 2012. THE ORGANISM WAS (B)(6). THE CATHETER WAS REMOVED DUE TO AN INFECTION. THE PUMP AND CATHETER WERE EXPLANTED. THE PUMP WAS DELIVERING FENTANYL.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED. HCP REPORTED THAT ON (B)(6) PATIENT SAW HER FAMILY DOCTOR AND WAS COMPLAINING OF MINOR BACK WOULD SKIN DEHISCENCE, BENIGN SEROMA AND IT WAS ADVISED AT THIS TIME THAT THE SKIN EDGES BE RE-SUTURED. OVER THE FOLLOWING 36 HOURS SHE BECAME PROGRESSIVELY WORSE. SHE WAS SEEN IN THE ER BY HCP ON (B)(6) 2012 WITH A RAPIDLY PROGRESSING CELLULITIS AND GROSS PURULENT DRAINAGE FROM HER BACK WOUND. SHE HAD SIGNS AND SYMPTOMS OF ¿MENINGISMUS¿, BACK AND NEW MUSCULAR TENSION, AND HEADACHE, BUT NO ACUTE MENINGITIS. IT WAS ALSO REPORTED CATHETER WAS DISCARDED BY HOSPITAL AND NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention