PRECISION Adverse Event — Malfunction (MDR 2029203-2008-00078)
PRECISION Adverse Event — Malfunction (MDR 2029203-2008-00078) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PRECISION; Generic name: SPINAL CORD STIMULATOR; Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION CORP..
| Device | PRECISION |
|---|---|
| Generic name | SPINAL CORD STIMULATOR |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION CORP. |
| Report number | 2029203-2008-00078 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Company representation |
| Narrative | DURING A PROGRAMMING SESSION, COMMUNICATION ISSUES BETWEEN THE IMPLANT AND THE EXTERNAL EQUIPMENT WAS OBSERVED. A BOSTON SCIENTIFIC REP PERFORMED DEVICE EVAL. THE PROBLEM WAS CONFIRMED. EXPLANT SURGERY HAS BEEN RECOMMENDED. |
| Source | openFDA MAUDE (device adverse events) |
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