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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUROITRELIPG

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NEURO ITREL IPG   Back to Search Results
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.

 
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Brand NameITREL
Type of DeviceIPG
Baseline Brand NameITREL
Baseline Generic NameIMPLANTABLE PULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model NumberIPG
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 Key454338
MDR Report Key465394
Event Key441031
Report Number2182207-2003-00469
Device Sequence Number1
Product CodeGZB
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 Received06/06/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIPG
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Unknown
Date Manufacturer Received05/19/2003
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
#TreatmentTreatment Date
PROGRAMMER MODEL 8840
ACC MODEL 8870, LOT# NHH013349N.
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