SYNCHROMED II

MDR report key: 2931335 · Received January 28, 2013

Report

Report Number: 3004209178-2013-01033
Event Type: Injury
Date Received: January 28, 2013
Report Date: January 9, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT EXPERIENCED A RETURN OF PAIN SYMPTOMS THAT WAS GRADUAL. HCP ADJUSTED THE MEDICATION. THE PATIENT CONTINUED TO EXPERIENCE AN INCREASE IN PAIN. A CATHETER DYE STUDY WAS PERFORMED AND REVEALED THE CATHETER WAS FRACTURED AT THE ANCHOR SITE. THE FRACTURE WAS A "CLEAN CUT". DURING THE REVISION IT WAS NOTED THAT THE CATHETER WAS FRACTURED APPROXIMATELY TWO CM DISTAL TO THE ANCHOR BELOW THE LIGAMENT. HCP REPLACED THE SPINAL SEGMENT AND ATTACHED THE PROXIMAL SEGMENT TO THE NEW SPINAL. THE PATIENT WAS NOT LEAKING CEREBROSPINAL FLUID FROM THE EXISTING FRACTURED SEGMENT STILL IN SPINE. HCP "TIED OFF" THE SPINAL SEGMENT THAT REMAINED. TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRED. THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PHYSICIAN PROGRAMMER SHOWED THAT 21.6 ML HAD INFUSED. THE HCP PLANNED TO FILL THE PUMP WITH MORPHINE FOLLOWING THE PROCEDURE. THE PUMP WAS CURRENTLY DELIVERING FENTANYL, HYDROMORPHONE, CLONIDINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
38052	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention