ACTIVA PC

MDR report key: 1812498 · Received August 16, 2010

Report

Report Number: 3007566237-2010-06146
Event Type: Injury
Date Received: August 16, 2010
Date of Event: July 19, 2010
Report Date: July 19, 2010
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PHYSICIAN PROGRAMMED A CYCLING IN THERAPY: TWENTY-FOUR HOURS ON AND TWENTY-FOUR HOURS OFF. THE DEVICE USAGE HISTORY DID NOT SHOW WHEN THE STIMULATION WAS ON OR OFF. THE STIMULATOR INDICATED THAT STIMULATION HAD BEEN ON ONE-HUNDRED PERCENT OF THE TIME. THE PHYSICIAN STATED THAT HAVING NO PROOF OF WHETHER STIMULATION WAS ON OR OFF, WAS NOT IDEAL. IT WAS NOTED THAT THE DEVICE WAS REPLACED. A REPORT STATED THAT IN THIS CASE IT SHOULD BE INTERPRETED THAT THE DEVICE WAS IN CYCLING MODE 100% OF THE TIME. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACTIVA PC		MHY	MEDTRONIC NEUROMODULATION	37601	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention