DEEP BRAIN STIMULATION LEAD (L-SIDED) Adverse Event — Injury (MDR 2182207-2008-00707)
DEEP BRAIN STIMULATION LEAD (L-SIDED) Adverse Event — Injury (MDR 2182207-2008-00707) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DEEP BRAIN STIMULATION LEAD (L-SIDED); Manufacturer: NEUROLOGICAL DIVISION, MEDTRONIC, INC.; Report number: 2182207-2008-00707.
| Device | DEEP BRAIN STIMULATION LEAD (L-SIDED) |
|---|---|
| Manufacturer | NEUROLOGICAL DIVISION, MEDTRONIC, INC. |
| Report number | 2182207-2008-00707 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Company representation |
| Narrative | THE REPRESENTATIVE REPORTED THAT TWO DBS LEADS HAD BEEN PLACED FOR A STAGE 1, DBS LEAD IMPLANT PROCEDURE. THE FOLLOWING DAY THE PATIENT HAD ONE SEIZURE IN THE HOSPITAL; IT WAS UNCONFIRMED IF IT HAD BEEN A GRAND MAL SEIZURE OR IF THE PATIENT HAD A HISTORY OF SEIZURES. THE PHYSICIAN SUSPECTED SWELLING AT THE LEFT LEAD IMPLANT SITE IN THE BRAIN; MRI TESTING WAS CONSIDERED AND COMPATABILITY INFORMATIO |
| Source | openFDA MAUDE (device adverse events) |
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