MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-24 for MRII TWIST DRILL ED-800047 NGS-HG-01 manufactured by Mri Interventions Inc.
[73556906]
There was no suggestion by the health professionals that the twist drill or drill bits failed to meet specification. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[73556907]
The twist drill was used to prepare 3. 4 mm pilot hole, followed by a 4. 5 mm bit to provide larger access to the frontal lobe lesion. During biopsy of the lesion, it was noted that there was a larger than normal amount of blood. Subsequent mri scans confirmed some blood in the subarachnoid space and subdural. The case was aborted. Patient was removed from the mri scanner, into the operating room for a craniotomy to remove the blood. On the subsequent friday the (b)(6), patient presented hemiplegic, with re-accumulation of blood visible on ct, so a second craniotomy was performed. The patient is doing well, with no expected continued deficit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125732-2017-00001 |
| MDR Report Key | 6517011 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-04-24 |
| 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 | MR. PETER PIFERI |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499006833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRII TWIST DRILL |
| Generic Name | CRANIAL DRILL |
| Product Code | HBG |
| Date Received | 2017-04-24 |
| Model Number | ED-800047 |
| Catalog Number | NGS-HG-01 |
| Lot Number | FA1610030 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MRI INTERVENTIONS INC |
| Manufacturer Address | 5 MUSICK IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-24 |