MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-20 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
| Report Number | 9612186-2020-00000 |
| MDR Report Key | 9860850 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INSTRUMENT AB |
| Manufacturer Street | KUNGSTENSGATAN 18 PO BOX 7593 |
| Manufacturer City | STOCKHOLM, SE10393 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE103 93 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE PERFEXION |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2020-03-20 |
| Lot Number | 6001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | KUNGSTENSGATAN 18 PO BOX 7593 STOCKHOLM, SE10393 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |