MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-27 for OPTUNE TFH-91000 N/A manufactured by Novocure, Ltd..
[112442638]
Novocure medical opinion is that although the prescriber assessed this event as not related to optune, a contribution of array placement to the events of wound infection and wound dehiscence cannot be ruled out. Contributing factors for wound dehiscence/wound infection in this patient also include prior radiation, chemotherapy, and prior surgery affecting skin integrity. Wound dehiscence was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only. Wound infection was reported in the ef-14 trial in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).
Patient Sequence No: 1, Text Type: N, H10
[112442639]
A (b)(6) female with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018. On (b)(6) 2018, the patient reported that she had recently had skin graft on the top of her head. Per hospital summary, patient underwent wound revision surgery on (b)(6) 2018 due to persistent wound infection and wound dehiscence from her previous resection surgery ((b)(6) 2017) and programmable valve placement ((b)(6) 2017). Patient was discharged on an unknown date with jp drain in place and optune treatment continued. On (b)(6) 2018, the patient was hospitalized with headaches, memory problems, neck stiffness and photophobia. Lumbar puncture (lp) at admission showed an opening pressure of 14 and a closing pressure of 4 after 8 cc fluid removal. Repeat lp showed an opening pressure of 11 and 15 cc fluid was removed. There was concern for possible shunt infection, but all cultures were negative and incision appeared to be healing normally. Jp drain was removed. Patient was discharged on (b)(6) 2018 in improved condition with a plan for repeat lp in one week. The prescribing physician stated that the events were not related to optune therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009453079-2018-00102 |
| MDR Report Key | 7641315 |
| Report Source | CONSUMER |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2016-10-06 |
| Date Added to Maude | 2018-06-27 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. EILON KIRSON |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31905 |
| Manufacturer G1 | NOVOCURE, LTD. |
| Manufacturer Street | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR |
| Manufacturer City | HAIFA, 31905 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31905 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTUNE |
| Generic Name | OPTUNE |
| Product Code | NZK |
| Date Received | 2018-06-27 |
| Model Number | TFH-91000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOCURE, LTD. |
| Manufacturer Address | TOPAZ BUILDING, SHA'AR HACARMEL 4TH FLOOR HAIFA, 31905 IS 31905 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-27 |