MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN AQM DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK AQM DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Chiang, c.; vipparthy, s.; talha ayub, m.; trohman, r.G.; larsen, t.R.; huang, h.D.; krishnan, k.; engelstein, e.D.; haw, j.M.; sharma, p.S.; wasserlauf, j.: comparison of electrocautery platforms for pulse generator replacement procedures; journal of interventional cardiac electrophysiology (2022) 64:557¿558; doi.Org/10.1007/s10840-022-01261-6.Background: insulated electrocautery devices were developed to reduce such complications.A limited area of thermal output minimizes collateral damage near the leads and allows for more precise dissection and coagulation.Two such devices are plasmablade (pl; medtronic inc., (b)(4)) and photonblade (ph; stryker, (b)(4)).Methods: we designed a single-center, retrospective cohort study including adults who underwent cied generator replacement procedures between 2017 and 2020 using pl or ph.The choice of device was based on institutional availability and operator preference.Results: a total of 209 patients were included in our analysis, with 86 (41.1%) in the pl cohort and 123 (58.9%) in the ph cohort.The mean age was 69 years (range 22¿97).Besides more men in the pl group (61, 70.9%, p=0.006), there were no other differences in baseline demographics.Conclusions: the primary endpoint of lead damage occurred in 0 patients in the pl cohort compared with 1 patient (0.8%) in ph cohort (p=0.59).The overall complication rate was low and not statistically different between the two groups.Either pl or ph may be preferable over el in specific instances when leads are comprised of polyurethane or copolymer insulation, or when extensive cautery is needed to improve visualization of leads or to facilitate explanation of a generator from the pocket.Reportable events: it was reported that there were 3 complications (3.4%) in the pl group, including 1 superficial infection treated with oral antibiotics, 1 infection requiring device removal, and 1 pocket hematoma, which was treated conservatively.

Manufacturer Narrative

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: UNKNOWN AQM DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15614768
• MDR Text Key: 301826099
• Report Number: 1226420-2022-00045
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK AQM DEV
• Device Catalogue Number: MAE UNK AQM DEV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention