MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC STIMLOC; COVER, BURR HOLE

Model Number 924256

Device Problem Unstable (1667)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The healthcare provider (hcp) reported via a manufacturer representative (rep) that the "pacman" did not hold the lead securely in place.The lead moved back and forth while the window was closed.The healthcare provider (hcp) opened the window on the "pacman" and closed it again several times with the same non-satisfactory result.They opened and used a different "pacman" from a stimloc spare parts kit and the issue was resolved.The patient's indication(s) for use were essential tremor and movement disorders.

Manufacturer Narrative

Note: there were no applicable fdrs related to stimlock burrhole cover so it was left blank for the report.Product analysis #701373613:the returned clip was tested with a known good base, cap and lead.With the clip inserted into the base and a lead passed through the clip, it closed onto the lead without difficulty and held the lead securely.The cap was also attached with no issues observed.The system was able to hold a lead securely in place, exceeding the 0.5lb retention force stated in the product specification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H6: due to imdrf harmonization, the codes have been updated to the most current coding.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STIMLOC
• Type of Device: COVER, BURR HOLE
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 5770191
• MDR Text Key: 49550149
• Report Number: 3012165443-2016-00008
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• PMA/PMN Number: K001096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2021

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: 02/01/2019
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Device Lot Number: 082203216A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/05/2016
• Supplement Dates Manufacturer Received: Not provided; 07/11/2016; 08/10/2021
• Supplement Dates FDA Received: 08/03/2016; 09/24/2017; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR