MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SPENCER DEPTH ELECTRODE; SD DEPTH ELECTRODE

Model Number SD08R-SP10X-000

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

An internal complaint investigation was performed for this issue.Specifically, a batch record review was conducted for the impacted depth electrode and no issues were noted that would contribute to the reported complaint; all manufactured electrodes passed the in-process and final quality control (qc) checks.According to report mw5081552, the device is available for evaluation.However to date, a product return analysis has not been performed for this complaint as ad-tech is still awaiting a response from the customer to obtain the product for evaluation.Multiple attempts have been made to contact the customer.A historical complaints review was also completed for the alleged deficiency "portion of electrode retained".There has been one (1) similar complaint for a portion of the depth electrode being retained between january 1, 2016 and december 10, 2018.Mdr 2183456-2016-00001 was initiated for this similar complaint and based on the investigation, it was stated that it was possible that when the patient seizured, the patient may have tugged on the cabling with enough force to sever the electrode.Historically, ad-tech has received complaints of similar nature for subdural strip electrodes.Due to the number of subdural complaints received, a corrective action/preventive action (capa) investigation was initiated to address this issue in may 2014.The probable root cause for this issue (disc dislodgement) was found to be due to percutaneous removal of the electrodes by the end user at bedside.Within the past 2 years (january 1, 2016 to december 10, 2018), ad-tech has received 2 additional complaints for subdural strip electrodes where discs have been left behind subsequent to percutaneous removal of the electrodes at bedside.Mdrs 2183456-2017-00008 and 2183456-2017-00011 were initiated for these complaints as well.As stated in the describe event section, the distal end of the 8-contact depth electrode was retained as a result of a planned electrode removal at bedside (i.E., percutaneous removal).According to ad-tech's directions for use (dfu), it specifically states that ad-tech's "sd" style depth electrodes are to be removed surgically.Additionally, it is stated that the depth electrodes should be handled with care to prevent damage (i.E., no direct pull or stress on the electrode).Percutaneous removal of the depth electrode at bedside is not recommended as it could potentially produce enough of a direct pull or stress on the electrode to cause retention of a portion of the electrode in the patient, as seen in this current event.The investigation is still on-going as ad-tech is awaiting further information from the customer.

Event Description

On december 10, 2018, ad-tech received a sus voluntary event report (freedom of information (foi) for manufacturers), mw5081552, from the fda.The medical device report (mdr) was voluntarily filed by the customer after they experienced an issue that involved an ad-tech depth electrode.The report stated that the patient underwent a craniotomy in the operating room for depth electrodes placement to allow for invasive eeg monitoring on the inpatient unit.During the planned electrode removal at bedside, the distal end of the 8-contact depth electrode was retained.One of the depth electrodes has a shear in it just past the first contact.According to report mw5081552, the customer categorized this event type as "serious injury" requiring intervention.Ad-tech requested additional information in regards to this event.To date, the customer has not responded back.It is unknown what the outcome or current status is of the patient.A supplement report will be initiated should ad-tech receive additional information relevant to this medwatch report.

• Brand Name: SPENCER DEPTH ELECTRODE
• Type of Device: SD DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: kathleen barlow ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 8227138
• MDR Text Key: 133937418
• Report Number: 2183456-2018-00007
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823107718
• UDI-Public: (01)00841823107718(17)200901(10)0123457208140688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: SD08R-SP10X-000
• Device Catalogue Number: SD08R-SP10X-000
• Device Lot Number: 208140688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other