MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-18 for SPENCER PROBE DEPTH ELECTRODE UNKNOWN manufactured by Ad-tech Medical Instrument Corp..
[38538172]
The investigation of this event is actively ongoing by the ad-tech complaint investigation team (cit). The status of the investigation is summarized as: this is the first report of a spencer probe depth electrode separation during a seizure. (b)(6) did not report any prior events of this same device concern. Ad-tech has not received any prior reports of spencer probe depth electrode separation during patient seizure from other device customers. There is no identified trend of spencer probe depth electrode separation during patient seizure. (b)(6) was contacted for additional information, including return of the spencer probe depth electrode reported to have separated. Ad-tech has not yet received the spencer probe depth electrode from (b)(6) services to support investigation.
Patient Sequence No: 1, Text Type: N, H10
[38538173]
On (b)(6) 2016, ad-tech medical instrument corporation (ad-tech) received email correspondence from (b)(6) centre with regard to a report of a spencer probe depth electrode separating in a patient during a seizure. The seizure related electrode separation event was reported to have happened on (b)(6) 2015. The patient was made aware of the retained electrode within his/her brain during the preoperative consultation and was told that it would be removed during the next surgery. The separated piece of the electrode was removed surgically from the patient on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[46133702]
There have been 0 similar complaints for depth electrodes breaking off in the brain between january 1, 2014 and january 20, 2016. Additionally, there have been no corrective action/preventive actions (capas) or investigations for the alleged deficiency between january 1, 2014 and february 19, 2016. The customer provided a list of products used in the surgery as it was unclear which electrode was severed. Device history records for 9 batches were reviewed. No issues were noted and all other electrodes and anchor bolts passed all in-process and final qc checks. The product was returned to ad-tech on 2/29/2016. According to the return analysis, it was found that only a piece of an rd electrode was received. The piece appeared to have ripped by contact #5 on the brain end and a dent on contact #5 was noticed. The catalog number of the electrode was not able to be obtained through this complaint return analysis. Based on this information, the return evaluation does support the alleged deficiency reported in the complaint. Per the product feedback form from alberta health, the other end of the electrode was not saved. It is possible that when the patient seizured, the patient may have tugged on the cabling with enough force to sever the electrode. As this cause is considered a probable cause and this is an isolated incident, no corrective actions can/will be assigned at this time. The risk level is classified as alap (as low as possible).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2016-00001 |
| MDR Report Key | 5445518 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-18 |
| Date of Report | 2016-05-25 |
| Date of Event | 2015-09-24 |
| Date Mfgr Received | 2016-01-20 |
| Date Added to Maude | 2016-02-18 |
| 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 | MS KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| 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 STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPENCER PROBE DEPTH ELECTRODE |
| Generic Name | SPENCER PROBE DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2016-02-18 |
| Returned To Mfg | 2016-02-29 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-18 |