FDA Adverse Event Injury Summary report: N

INFUSION PUMP, UNKNOWN

MDR report key: 3875369 · Received June 16, 2014

Report

Report Number: 3007566237-2014-01670
Event Type: Injury
Date Received: June 16, 2014
Report Date: May 27, 2014
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_ UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD MENINGITIS FROM A PREVIOUS BACK SURGERY UNRELATED TO THE PUMP WHICH RESULTED IN THEM REMOVING THE PUMP AND CATHETER. IT WAS THOUGHT THAT "THIS MAY HAVE LEFT THE PATIENT WITH ADHESION OR SCAR TISSUE. " THE PUMP WAS INFUSING AN UNKNOWN DRUG. IT WAS LATER REPORTED THAT THE PATIENT'S PREVIOUS PUMP AND CATHETER HAD BEEN REMOVED A YEAR OR MORE PRIOR TO REPORT, BUT THAT THE EXACT DATE WAS UNKNOWN. IT WAS NOTED THAT "BY REPORT, PATIENT HAD THE PUMP PLACED, BACK SURGERY, INFECTION, THEN REMOVAL OF THE PUMP AND CATHETER." IT WAS NOTED THAT THE PAIN DRUG WAS UNKNOWN BUT THAT IT WAS NOT BACLOFEN. IT WAS CLARIFIED THAT THE PHYSICIAN STATED THAT THE INFECTION WAS A RESULT OF THE ORTHOPEDIC BACK SURGERY AND WAS UNRELATED TO THE PUMP BUT HE WAS ASKED TO REMOVE THE IMPLANTS TO HELP CLEAR THE INFECTION. IT WAS NOTED THAT THE INFECTION WAS CLEARED AND THE PATIENT WAS PRESENTED IN THE OPERATING ROOM FOR PUMP PLACEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352642	INFUSION PUMP, UNKNOWN	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	NEU_UNKNOWN_PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention