MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-01-08 for CLEARPOINT SYSTEM manufactured by Mri Interventions, Inc..
[21949403]
To our knowledge, there has been no suggestion of failure or malfunction of any component of the clearpoint system made or alleged by the institution or other health professional.
Patient Sequence No: 1, Text Type: N, H10
[22041893]
The clearpoint system was used by surgeons at (b)(6). The pt developed complications following the procedure and passed away due to these complications. There has been no allegation such complications were due from any malfunction of the clearpoint system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125732-2013-00001 |
| MDR Report Key | 2909376 |
| Report Source | 08 |
| Date Received | 2013-01-08 |
| Date of Report | 2013-01-09 |
| Date of Event | 2012-12-10 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-01-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | E WADDELL, DIRECTOR |
| Manufacturer Street | 5 MUSICK |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9499006833 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARPOINT SYSTEM |
| Generic Name | NEUROLOGIC STEREOTAXIC, 21CFR 882.4560 |
| Product Code | ORR |
| Date Received | 2013-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MRI INTERVENTIONS, INC. |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-01-08 |