SYMMIX 3982 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-07 for SYMMIX 3982 NA manufactured by Medtronic Inc..

Event Text Entries

[66065] Pt began complaining of sudden onset of severe pain in her thoracic area, adjacent to the site of her laminectomy. Pt felt severe pain when the physician merely stroked the skin in the area. Physician likened the pain to that associated with shingles. Turning the pulse generator off made no difference in the pt's level of pain, leading the physician to believe that the electrode may be touching one of the thoracic nerves. Physician removed the pt's entire stimulation system, and upon explant, noted that the wires in the lead looked twisted. The system was returned to the mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000032-1997-00186
MDR Report Key104336
Report Source05
Date Received1997-07-07
Date of Report1997-05-28
Date of Event1997-05-01
Date Mfgr Received1997-05-28
Device Manufacturer Date1994-05-01
Date Added to Maude1997-07-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYMMIX
Generic NameIMPLANTABLE STIMULATION LEAD
Product CodeLHG
Date Received1997-07-07
Returned To Mfg1997-05-28
Model Number3982
Catalog NumberNA
Lot NumberL33534
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age12 MO
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key102651
ManufacturerMEDTRONIC INC.
Manufacturer Address800 53RD AVE NE MINNEAPOLIS MN 55421 US
Baseline Brand NameSYMMIX
Baseline Generic NameSURGICAL EPIDURAL LEAD
Baseline Model No3982
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilySTIM SYMMIX LEAD
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]48
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK913934
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1997-07-07

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