MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for SD DEPTH ELECTRODE SD08R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[188726722]
Mdr 2183456-2019-00021 has been filed past the 30-day timeframe. Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur. As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Patient Sequence No: 1, Text Type: N, H10
[188726743]
On april 15, 2019, an ad-tech clinical specialist reported that during a case they attended the surgeon encountered an issue after implanting four ad-tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes were in fact 6 contact depth electrodes. There was no impact to the patient due to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2019-00021 |
| MDR Report Key | 9654450 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2020-01-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PAMELA STOGSDILL |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK WI 53154 |
| Manufacturer Country | US |
| Manufacturer Postal | 53154 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK WI 53154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SD DEPTH ELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2019-04-16 |
| Model Number | SD08R-SP05X-000 |
| Catalog Number | SD08R-SP05X-000 |
| Lot Number | 208140699 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 WEST OAKVIEW PARKWAY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |