MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-12 for PLASMABLADE 4.0 GENERAL SURGERY PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[21177038]
Plasmablade was activated and the pacing output of the pacemaker was reduced from 70bpm to 40bpm and when the plasmablade was deactivated the pacemaker output did not recover to 70bpm. In order to reset the pacemaker to 70bpm the voltage on the pacemaker had to be increased. Use of plasmablade was terminated. 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). (b)(4): via retrospective review of complaints associated with pacemaker interference, this pe was determined to be reportable. Date of retrospective review (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[21299114]
(b)(4). (method), (result) and (conclusion): device not returned; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00084 |
| MDR Report Key | 4085513 |
| Report Source | 06,07 |
| Date Received | 2014-09-12 |
| Date of Report | 2013-10-25 |
| Date of Event | 2013-10-24 |
| Date Mfgr Received | 2013-10-25 |
| Date Added to Maude | 2014-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMABLADE 4.0 GENERAL SURGERY |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-09-12 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |