OCTRODE LEAD KIT, 60CM LENGTH Adverse Event — Injury (MDR 3006705815-2020-01727)
OCTRODE LEAD KIT, 60CM LENGTH Adverse Event — Injury (MDR 3006705815-2020-01727) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OCTRODE LEAD KIT, 60CM LENGTH; Generic name: PERCUTANEOUS LEAD; Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC).
| Device | OCTRODE LEAD KIT, 60CM LENGTH |
|---|---|
| Generic name | PERCUTANEOUS LEAD |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
| Report number | 3006705815-2020-01727 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE REPORTED EVENT FOR HIGH IMPEDANCE WAS CONFIRMED. AS RECEIVED, THE OCTRODE LEAD WAS COMPLETE. MICROSCOPIC INSPECTION IDENTIFIED A KINK WITH MULTIPLE BROKEN WIRES; CONSISTENT WITH OVERSTRESS CONDITION THAT THE LEAD WAS SUBJECTED WHILE IN VIVO. |
| Source | openFDA MAUDE (device adverse events) |
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