| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NEUROMONICS OASIS TINNITUS TREATMENT DEVICE | OASIS TINNITUS TREATMENT DEVICE | NEUROMONICS INC. | KLW | 110 | NA | NA | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-02-03 | 0 |
Patient 1
PT PLUGGED IN THE DEVICE TO CHARGE IT AND PLACED IT ON A GRANITE BENCHTOP. THE DEVICE WAS CONTAINED IN ITS CARRYING POUCH. THE UNIT OVERHEATED RAPIDLY AND BEGAN TO EMIT FLAMES. PT THREW THE DEVICE IN A NEARBY SINK TO EXTINGUISH THE FLAMES AND REPORTED THAT HIS THUMB WAS BLISTERED IN THE PROCESS. PT DID NOT ELECT TO SEEK MEDICAL TREATMENT FOR THE BLISTERING. THE DEVICE WAS SIGNIFICANTLY DAMAGED AND THERE WAS SOME SMOKE PRODUCED.
Patient 1
FOLLOW-UP WITH THE PT INDICATED NO MEDICAL INTERVENTION, SERIOUS INJURY, OR SUBSEQUENT EFFECTS FROM THE INCIDENT. IGNITION IS BELIEVED TO HAVE BEEN CAUSED BY A THERMAL RUNAWAY OF THE BATTERY WHEN CHARGING WAS INITIATED. THE PT HAD NOTED THAT THE UNIT HAD BEEN CHARGED ALMOST DAILY DURING THE PREVIOUS 18 MONTHS OF USAGE WITHOUT ANY ISSUES. INVESTIGATION TO DATE HAS INCLUDED: REVIEW AND ANALYSIS OF THE MALFUNCTIONING UNIT IN CONJUNCTION WITH THE BATTERY MANUFACTURER; REVIEW OF DESIGN; REVIEW OF VERIFICATION TESTS, ASSEMBLY PROCEDURES, AND MANUFACTURING RECORDS FOR THE MALFUNCTIONING UNIT AND OTHER UNITS. THIS CURRENTLY APPEARS TO BE AN ISOLATED EVENT CONSIDERING THE LARGE NUMBER OF UNITS MANUFACTURED WITHOUT SIMILAR INCIDENTS, AND CIRCUITRY/PHYSICAL DESIGN INTENDED TO MITIGATE RISKS ASSOCIATED WITH THE USE OF RECHARGEABLE BATTERIES. THE REVIEW PROCESS CONTINUES IN CONJUNCTION WITH THE BATTERY SUPPLIER, CONTRACT MANUFACTURER AND PRODUCT DESIGNER EFFORTS TO IDENTIFY POTENTIAL ROOT CAUSES AND EVALUATE THE RISK OF RECURRENCE. SUPPLEMENTARY INFO WILL BE PROVIDED IF FURTHER PERTINENT INFO IS IDENTIFIED.