MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-07 for ELECTRODE, DEPTH SD08R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[16882341]
Ad-tech received an email from a customer stating that during an implantation case, an issue was identified with a depth electrode, where the style could not be removed from the electrode. The electrode with stylet was removed from the brain. There were no medical interventions required. Another electrode was used without the same issue occurring. It was also stated that the pt went on to continue his stay in the monitoring unit without any problems. Ad-tech's complaint investigation team determined that an mdr be filed for this issue due to a precedence that was set for filing on sticking stylet issues beginning with mdr 2183456-2015-00001.
Patient Sequence No: 1, Text Type: D, B5
[17114128]
Ad-tech is currently in the process of investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2015-00005 |
| MDR Report Key | 4901454 |
| Report Source | 05 |
| Date Received | 2015-07-07 |
| Date of Report | 2015-02-04 |
| Date of Event | 2015-01-25 |
| Date Mfgr Received | 2015-02-04 |
| Device Manufacturer Date | 2014-11-13 |
| Date Added to Maude | 2015-07-31 |
| 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 | MS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404566 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 5668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRODE, DEPTH |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2015-07-07 |
| Returned To Mfg | 2015-02-19 |
| Catalog Number | SD08R-SP05X-000 |
| Lot Number | 208140568 |
| Device Expiration Date | 2016-11-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM ST. RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-07 |