ACTIVA

MDR report key: 2860545 · Received December 6, 2012

Report

Report Number: 3004209178-2012-11252
Event Type: Injury
Date Received: December 6, 2012
Report Date: July 29, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 64002, LOT# N269748, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389-40, LOT# J0546462V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3389-40, LOT# J0546462V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT HAD HAD HALLUCINATIONS. INFORMATION ON WHETHER A SLEEP NUMBER BED COULD HAVE CAUSED HALLUCINATIONS WAS QUESTIONED. IT WAS ALSO NOTED THE DEVICE HAD NOT TAKEN AWAY MANY OF THE PARKINSON'S SYMPTOMS AND FOR THE PRIOR THREE WEEKS THE PATIENT HAD HAD A LOT OF HALLUCINATIONS. IT WAS NOTED THE PATIENT HAD HALLUCINATIONS PRIOR TO IMPLANT. IT WAS NOTED THE PATIENT HAD DETERIORATION OF THEIR BLADDER, INTESTINES AND MIND. PATIENT WAS SCHEDULE FOR APPOINTMENT WITH HEALTH CARE PROFESSIONAL. FOLLOW UP REPORTED THE CAUSE OF THE EVENT WAS MEDICATION INDUCED. THERE WERE NO ABNORMAL IMPEDANCES. THERE WAS NO INJURY TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MDT PUERTO RICO OPERATIONS CO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1	00064 YR		Other