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 PULSAR 2 GENERATOR PS100-102 manufactured by Medtronic Advanced Energy, Llc.
[4896283]
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
[12187183]
(b)(4). Evaluation process: unit received in poor condition with gouges in surface and scratches on front panel overlay (enclosure will be replaced. ) a power cord was received with unit. No user manual nor hand pieces were received. Internal visual inspection revealed no loose or broken components. Unit delivered rf energy correctly into fixed resistors. Root cause: the generator was found to be correctly delivered rated power to rated loads upon receipt. The pulsar ii is an electro surgery device and, as such, is considered an intentional radiator of rf energy when keyed (via foot pedal or hand piece activation. ) all equipment in the or should be designed to withstand the emi interference generated by the pulsar ii rf generator (per (b)(4) requirements. ) the pulsar ii rf generator is functioning as designed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00083 |
| MDR Report Key | 4085460 |
| 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 | PULSAR 2 GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-09-12 |
| Returned To Mfg | 2013-11-12 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |