MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-10-12 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
[57139802]
Device in clinical use.
Patient Sequence No: 1, Text Type: N, H10
[57139803]
A patient had an intracranial bleed during a gamma knife treatment. The patient was being treated for intracranial metastatic brian lesions, of origin from melanoma. We understand the patient has since passed away.
Patient Sequence No: 1, Text Type: D, B5
[73914497]
Patient suffered an intracranial bleed following an lgk treatment. The patient was being treated for intracranial metastatic brain lesions, of origin from melanoma. The patient is deceased. The device was used within its intended use and worked as intended. Treatment was per available information performed in two sessions, whereas complications occurred after the second session. Upon ct examination a haemorrhage was identified as being associated with the location fo the first treatment and one smaller associated with the second treatment. The cause of death is not known as the patient was sent to another hospital for treatment. The gamma knife did operate as intended according to the information from the doctor at site. No new risks have been identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2016-00007 |
| MDR Report Key | 6020986 |
| Report Source | OTHER |
| Date Received | 2016-10-12 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-06-21 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-10-12 |
| 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 | 2016-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Death | 2016-10-12 |