MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for DEPTH ELECTRODE SD06R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[188727935]
Mdr 2183456-2019-00017 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 serioius injury had occured, 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. Clinician contacted ad-tech due to repeated occurrences of depth electrode getting caught on bone during explant. After review, an ad-tech clinical specialist was able to recommend an alternative accessory for assisting explant which was reported as successful in a future case.
Patient Sequence No: 1, Text Type: N, H10
[188727936]
On december 11, 2018 ad-tech received a query from a customer asking for advice on removal technique for depth electrodes, indicating that they had experienced some instances in which the electrode goes in without difficulty, but upon explant the contact appears to get stuck on the edge of the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2019-00017 |
| MDR Report Key | 9553477 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2020-01-06 |
| 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 | DEPTH ELECTRODE |
| Generic Name | SPENCER DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2020-01-06 |
| Catalog Number | SD06R-SP05X-000 |
| Lot Number | UNKNOWN |
| 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 | 400 WEST OAKVIEW PARKWAY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |