MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for CLEARPONIT SYSTEM SMART GRID SYSTEM manufactured by Mri Interventions Inc..
[129158860]
Surgeon does not fell clearpoint system was cause oif the event. The manufacturer of the mri table imris has been notified of table movement during procedure.
Patient Sequence No: 1, Text Type: N, H10
[129158861]
Following a bilateral dbs case, software team analyzed the data it was learned that the targeting sequences and the final t1 volume were not in the same mr space, and there had been a posterior shift requiring a second bilateral dbs case performed in another room. Root cause determined that the imris table moved during the first operation causing the targeting sequence to change.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002838670-2018-00004 |
| MDR Report Key | 8072173 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-11-03 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-14 |
| 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. PETE PIFERI |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499006833 |
| Manufacturer G1 | MRI INTERVENTIONS INC. |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLEARPONIT SYSTEM SMART GRID SYSTEM |
| Generic Name | SMARTGRID SYSTEM |
| Product Code | ORR |
| Date Received | 2018-11-14 |
| Model Number | NA |
| Lot Number | UNK |
| 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 | 2018-11-14 |