MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-18 for PMT SEEG DEPTHALON DEPTH ELECTRODE UNK manufactured by Pmt Corporation.
[16899909]
Pmt corporation received a medwatch on (b)(6) 2015 regarding a patient that had a metal fragment left behind after removal of depth electrode. Here is the original narrative from the medwatch received. "stereoelectroencephalography (seeg) leads were placed in early 2015 and removed 9 days later. After removal, an intra-operative x-ray showed several tiny metallic fragments near the skull based. This electrode tip was removed during an already planned secondary surgery. "
Patient Sequence No: 1, Text Type: D, B5
[17036643]
Pmt reviewed all information that was received from the user. The direct cause of the event is unable to be determined since the device and accompanying components were not returned for investigation/evaluation. The potential cause could be that the electrode tip somehow got lodged at the bottom of the anchor bolt when the surgeon was removing the electrode, causing the distal tip to break off and be left behind. However without evaluating the components, this is speculation. The user facility had no information regarding model numbers or lot numbers of the product reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182979-2015-00001 |
| MDR Report Key | 4863241 |
| Report Source | 05 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-01-22 |
| Date Mfgr Received | 2015-05-18 |
| Date Added to Maude | 2015-07-15 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM SCHMELZER |
| Manufacturer Street | 1500 PARK RD. P.O. OX 610 |
| Manufacturer City | CHANHASSEN MN 55317 |
| Manufacturer Country | US |
| Manufacturer Postal | 55317 |
| Manufacturer Phone | 9524700866 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PMT SEEG DEPTHALON DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2015-06-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PMT CORPORATION |
| Manufacturer Address | CHANHASSEN MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-18 |