SYNCHROMED II

MDR report key: 2478614 · Received March 5, 2012

Report

Report Number: 3007566237-2012-00468
Event Type: Malfunction
Date Received: March 5, 2012
Report Date: February 10, 2012
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PHYSICIAN PROGRAMMER MODEL 8840, SERIAL# UNK; CATHETER MODEL 8709, LOT# L73611, IMPLANTED: 2000-(B)(6), EXPLANTED: UNK.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT VISITED THE HEALTHCARE PROVIDER (HCP) ON 2012-(B)(6) FOR TREATMENT CHANGE. PATIENT FELT "LIKE SHE WAS NOT GETTING MEDICINE". IT WAS STATED THAT THE BASAL RATE WENT FROM 43.1MCG/HR TO 25 MCG/HR AND MULTIPLE BOLUSES AT 0000, 600, 1200, 1600 AND ONE TIME BOLUS AT 5 PM OF 200 MCG WAS STATED. PATIENT FELT "LIKE SHE WAS GOING THROUGH WITHDRAWALS". IT WAS NOTED THAT THE TOTAL DAILY DOSE HAD INCREASED FROM 1,224 TO 1,383 MCG/DAY. IT WAS LATER REPORTED THAT THE "PATIENT WAS PUT BACK TO PREVIOUS SETTINGS" PER HCP REQUEST. DRUG DELIVERED VIA THE DEVICE WAS NOT KNOWN TO THE REPORTER. REPORTER WAS UNSURE IF THERE WAS A PROGRAMMING ERROR.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCONTROLLED PAIN. PER THE HEALTH CARE PROVIDER, THE CAUSE OF THE EVENT WAS UNKNOWN; NOT EFFECTIVE DOSING. THERE WAS NO REPORTED INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE PUMP DELIVERED FENTANYL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1