FDA Adverse Event Injury Summary report: N

SYNCHROMED

MDR report key: 3800163 · Received May 8, 2014

Report

Report Number: 3007566237-2014-01277
Event Type: Injury
Date Received: May 8, 2014
Report Date: April 15, 2014
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PUMP, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N322028, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT HAD THE PUMP REMOVED DUE TO INFECTION. REPORTER INDICATED THIS WAS A PREVIOUS PUMP THAT WAS IMPLANTED APPROX. 3 YEARS AGO AND WAS REMOVED AFTER A WEEK DUE TO INFECTION (MANUFACTURER DEVICE REGISTRATION SYSTEM NOTED THAT PATIENT ONLY HAD ONE PREVIOUS PUMP THAT WAS IMPLANTED ON (B)(6) 2012 THAT WAS EXPLANTED ON (B)(6) 2014, AND NO PUMPS PRIOR TO THIS). PUMP HAD MORPHINE 10 MG/ML IN IT RUNNING AT 0.75 MG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
278847	SYNCHROMED	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	00047 YR		Required Intervention