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

Model Number MAE UNK DEV

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

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

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is not available.Patient gender is not available.Patient weight was not included in the journal article.Please note that this date is based off of the date the article was published as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Ananwattanasuk t, jamé s, bogun fm, chugh a, crawford t.C, cunnane r, ghanbari h, latchamsetty r, lathkar-pradhan s, oral h, pelosi f, saeed m, jongnarangsin k.; lead damage after cardiac implantable device replacement procedure: comparison between electrical plasma tool and electrocautery.J cardiovasc electrophysiol.2021; https://doi.Org/10.1111/jce.14966.Background: this study was designed to compare the effect of ec versus peak plasma blade on lead parameters and complications after generator replacement procedures.Methods: a total of 410 consecutive patients (840 leads) who underwent cied replacement using ec (ec group) and 410 consecutive patients (824 leads) using peak plasma blade (plasma blade group).Pacing lead impedance, incidence of lead damage, and complications were compared between both groups.Results: lead impedance increased in 393 leads (46.8%) in the ec group versus 282 leads (34.2%) in the plasma blade group (p <(><<)>.01) with average percent changes of 6.7% and 4.0% (p <(><<)>.01), respectively.Lead impedance decreased in 438 leads (52.1%) in the ec group versus 507 leads (61.5%) in the plasma blade group (p <(><<)>.01) with average percent changes of -5.7% and -7.1% (p <(><<)>.01), respectively.Lead damage requiring lead revision occurred in five leads (0.6%) or after five procedures (1.2%) in the ec group compared to three leads (0.4%, p =.50) or after three procedures (0.7%, p =.48) in the plasma blade group.There were no significant differences in the procedural-related complications between the ec group (nine patients, 2.2%) and the plasma blade group (five patients, 1.2%, p =.28).Conclusions: conventional electrocautery can potentially damage lead insulations.However, this study shows that when used carefully electrocautery is as safe as the peak plasma blade¿.Reported events: according to the literature, there were no significant differences in the procedural-related complications between the ec group and the plasma blade group (2.2% vs.1.2%, p =.28).In the ec group, lead damage requiring lead revision occurred in five patients.One patient had a pocket hematoma requiring evacuation and three developed a pocket infection requiring total system extraction.Similarly, in the plasma blade group, three patients required lead revision after lead damage, one patient had a pocket hematoma requiring evacuation and one patient developed a pocket infection requiring total system extraction.

• Brand Name: UNKNOWN MAE DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11813021
• MDR Text Key: 250453127
• Report Number: 1226420-2021-00088
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK DEV
• Device Catalogue Number: MAE UNK DEV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2021
• 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