FDA Adverse Event Other Summary report: N

RN SYSTEM

MDR report key: 641796 · Received August 22, 2005

Report

Report Number
641796
Event Type
Other
Date Received
August 22, 2005
Date of Event
April 22, 2005
Report Date
August 22, 2005
Manufacturer
NURSE ASSIST, INC
Product Code
ILQ
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED TO HOSPITAL INPATIENT BEHAVIORAL HEALTH UNIT WITH A DIAGNOSIS OF DEPRESSION. THE PATIENT HAD A HISTORY OF PARKINSONS DISEASE, AND PRIOR TO ADMISSION TO THE HOSPITAL, HIS NEUROLOGIST, PLACED A DBS (DEEP BRAIN STIMULATOR) TO TREAT THEIR SEVERE SYMPTOMS. AFTER THE DBS WAS PLACED, THE PATIENT BECAME PHYSICALLY AGGRESSIVE AND SEXUALLY PREOCCUPIED. THE PATIENT'S FAMILY AND THE NURSING HOME WERE UNABLE TO TAKE CARE OF THE PT. WAS HOSPITALIZED. ON THE MEDICAL FLOOR THE DBS WAS DISCONNECTED BY THE NEUROLOGIST. AFTER THIS THE PATIENT WAS NOT AGGRESSIVE, BUT BECAME DEPRESSED AND SUICIDAL, WHEN THE PARKINSONS SYMPTOMS RETURNED. THE PATIENT VERBALIZED SUICIDAL IDEATION INTERMITTENTLY, BUT DID NOT HAVE AN ACTIVE PLAN, AND WAS COMPLIANT WITH TREATMENT. SINCE THEIR PARKINSON'S SYMPTOMS WORSENED CONSIDERABLY, THE PT. WAS DEEMED AT HIGH RISK FOR FALLS AND WAS PLACED ON THE RN+ SYSTEM WITH PHYSICIAN'S ORDER. AFTER MEETING WITH THE PATIENT'S FAMILY, THE ATTENDING PSYCHIATRIST AND NEUROLOGIST AGREED TO RESUME USE OF THE DBS USING A LOWER LEVEL OF STIMULATION THEN THEY HAD PREVIOUSLY TRIED. INITIALLY, THE PATIENT EXPRESSED POSITIVE RESPONSE TO RELIEF OF HIS SYMPTOMS THE MORNING IT WAS ACTIVATED. THAT AFTERNOON AT LUNCHTIME, THE PATIENT WAS FOUND WITH THE RN+ CORD WRAPPED AROUND THEIR NECK BY A STAFF RN DOING ROUNDS. THE STAFF PROMPTLY REMOVED THE CORD, AND THE INCIDENT DID NOT INJURE THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RN SYSTEM FALL ALARM SENSOR PAD ILQ NURSE ASSIST, INC * *

Patients

Seq Age Sex Outcome Treatment
1 70 YR