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Submit date: 2/20/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
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An investigation was performed for the reported customer complaint: ¿the customer reported the gel on the pad has come away from the pad itself.¿ a review of the device history records (dhr) for product 22550pc, lot number 632146x, indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination.In addition, dhrs were reviewed for the hydrogel body subassembly utilized in product 22550pc, corresponding lot number 632146x.The production hydrogel body sub-assembly lot numbers, 628707 & 608842, did exhibit some minor aesthetic delamination.Aesthetic delamination will not significantly affect electrode function.These lots did not exhibit functional delamination, which is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.The dhr¿s for the hydrogel body sub-assemblies met all acceptance criteria.Raw material records were reviewed as well and all acceptance criteria were met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.The conductive silver/silver chloride ink and gel batch mix sheets were also reviewed.All components and mix time were within tolerance.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.A complaint sample was received in the form of one (1) defibrillator electrode set.The electrode was received in an open pouch identifying lot number 632146x.The reported event is commonly referred to gel delamination.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.During the production of hydrogel bodies, four-corner peel testing is performed to simulate the removal of the electrode release liner by a clinician prior to delivering therapy (corners of gel body are lifted from the liner to evaluate for release of gel from the substrate).During visual inspection, gel delamination from the substrate on the electrode set was observed on one of the two pads.The degree of delamination on the electrode pad was evaluated.The delamination did extend into the silver printed area and did include conductive mat area, as it extended into the conductive mat.However, the delamination was within acceptable levels.Five (5) retained production samples for lot 632146x were evaluated as well.None of the five (5) retained samples evaluated exhibited delamination.Potential root causes may include: the gel was insufficiently cured (the strength of the bond between the gel and the substrate was too weak) or there was insufficient silicone on the mylar liner (the strength of the bond between the gel and the plastic liner was too strong).The silver ink re-mixing was not adequately performed during the sub-assembly printing process.If not adequately re-mixed it may not properly dry which could result in gel not properly adhering to the silver printed substrate.This may contribute to gel delamination.Silver mixtures can become separated over time because they are suspensions; this is visually detectable prior to use.Gel delamination may become exacerbated if the defibrillator electrodes are improperly stored.Improper storage conditions and/or handling of the product may also compromise gel properties prior to the expiration.The environmental and handling condition in which the product was stored was not provided with the complaint.Product packaging, proper storage and usage of the electrodes are critical to the performance of the gel.None of the production records or incoming inspection records indicated any of these scenarios occurred.Gel delamination most likely occurred.The reported customer complaint is confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.
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