MAUDE Adverse Event Report: NEUROITRELIPG

Model Number IPG

Device Problem Device remains implanted

Event Date 04/03/2003

Event Type  Other   Patient Outcome  Other

Event Description

During review of a deep brain stimulator with an n'vision programmer, model 8840, the pt experienced severe rebound tremor which lasted approximately 5 minutes. The pt appeared rigid, not responding verbally to command and unable to talk. The tremor decreased in severity and the pt was able to relax. There was no loss of consciousness, no pain experienced, no drowsiness, no focal seizures and once the rigidity improved the pt was able to speak with no apparent dysarthria or dysphasia. Immediately after the incident the settings of the stimulator had altered to ov, pw 210 usec, rate 30hz. Electrode settings were as normal. The stimulator had been switched off and the battery was showing ok. The programmer was later needed to check the pt's stimulator again and to reprogram it. After reprogramming there was an immediate improvement in the pt's tremor. The pt remained in the hosp for another hour iwth a relative after the changes were made to ensure the pt was safe to go home. Previously in the same clinic the n'vision programmer had been used on three other outpatients, using the same routine, with no apparent problems. A follow-up report will be sent when additional info is received.

• Brand Name: ITREL
• Type of Device: IPG
• Baseline Brand Name: ITREL
• Baseline Generic Name: IMPLANTABLE PULSE GENERATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: IPG
• Manufacturer (Section F): NEURO; 800 53rd ave., n.e.; minneapolis MN 55421
• Manufacturer (Section D): NEURO; 800 53rd ave., n.e.; minneapolis MN 55421
• Manufacturer Contact: barbara pahl ; 710 medtronic parkway; mineapolis , MN 55432-5604; (763) 505 -0856
• Device Event Key: 454338
• MDR Report Key: 465394
• Event Key: 441031
• Report Number: 2182207-2003-00469
• Device Sequence Number: 1
• Product Code: GZB
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2003

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/06/2003
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: IPG
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: unknown
• Event Location: Unknown
• Date Manufacturer Received: 05/19/2003
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is the Device an Implant?: No
• Is this an Explanted Device?: Unknown
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/06/2003 Patient Sequence Number: 1

#	Treatment	Treatment Date
PROGRAMMER MODEL 8840
ACC MODEL 8870, LOT# NHH013349N.