UNKNOWN PLASMABLADE DEVICE

MDR report key: 3975908 · Received August 4, 2014

Report

Report Number: 1226420-2014-00058
Event Type: Malfunction
Date Received: August 4, 2014
Date of Event: October 9, 2013
Report Date: October 17, 2013
Manufacturer: MEDTRONIC ADVANCED ENERGY, LLC
Product Code: DWG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT# (B)(4). METHOD, RESULT: DEVICE DISCARDED THEREFORE ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

DURING A PACEMAKER GENERATOR EXCHANGE WITH A NON-PACEMAKER DEPENDENT PATIENT THE PLASMABLADE WAS ACTIVATED AND THE PACING OUTPUT OF THE PACEMAKER WAS INHIBITED. WHEN PLASMABLADE WAS DEACTIVATED THE PACEMAKER OUTPUT REMAINED INHIBITED FOR SEVERAL SECONDS BEFORE RESUMING NORMAL OPERATION. USE OF PLASMABLADE WAS TERMINATED AND STANDARD ELECTROCAUTERY WAS UTILIZED WITHOUT FURTHER INCIDENT. PACEMAKER BEING REPLACED WAS AT THE ERI (ELECTIVE REPLACEMENT INTERVAL = NEAR END OF BATTERY LIFE) REFERENCE LINK BELOW TO LETTER ISSUED BY ST. JUDE INDICATING THAT THE USE OF ELECTROSURGERY IN CONJUNCTION WITH CERTAIN PACEMAKER MODELS CAN RESULT IN A FUNCTIONAL IMPACT TO THE PACEMAKER (REDUCED OUTPUT OR LACK OF OUTPUT). HTTP://PROFESSIONAL.SJM.COM/PROFESSIONAL/RESOURCES/PRODUCT-PERFORMANCE/PACEMAKER-012914-COMMUNICATION/PHYSICIAN-COMMUNICATION 7/24/2014 (BOISVK1): VIA RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH PACEMAKER INTERFERENCE, THIS PE WAS DETERMINED TO BE REPORTABLE. DATE OF RETROSPECTIVE REVIEW (B)(4) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
453933	UNKNOWN PLASMABLADE DEVICE	ELECTROSURGICAL DEVICE	DWG	MEDTRONIC ADVANCED ENERGY, LLC	MAE UNK PEAK DEV	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1