MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-19 for SUBDURAL ELECTRODE UNK manufactured by Ad-tech Medical Instrument Corp..
[3754218]
It was initially reported to ad-tech on (b)(6) 2013 that there was an issue post-op where a pt was in a scan and they noticed that one platinum contact had dislodged from the electrode and remained in the pt.
Patient Sequence No: 1, Text Type: D, B5
[11123950]
On (b)(6) 2013, the customer provided ad-tech with the catalog numbers and lot numbers of all the electrodes used during the case, but was unable to provide the catalog and lot number of the electrode that malfunctioned. Date of implantation was (b)(6) 2013 through a burr hole and removal was (b)(6) 2013. Retained electrode was found during routine post operative films. Pt returned to the operating room for the removal of the retained electrode on (b)(6) 2013. There is no known adverse effect.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2013-00005 |
| MDR Report Key | 3389980 |
| Report Source | 05,06 |
| Date Received | 2013-09-19 |
| Date of Report | 2013-09-19 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-12-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2013-09-19 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-19 |