MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-08-22 for GENERATOR PULSAR II PS100-102 manufactured by Medtronic Advanced Energy, Llc.
[4846290]
During a pacemaker generator exchange procedure the plasmablade was activated and the pacemaker stopped pacing such that the patient did not have a hr. The strip from external defibrillator showed that the pacemaker was trying to pace but there was no output. Plasmablade activation was ceased and after approximately 30-40 seconds the pacemaker output and patient's hr returned to a normal rate (patient is pacemaker dependent). Temporary pacing was available but not utilized as pacemaker output and patient hr recovered before the temporary system could be utilized (30-40 seconds). Surgeon continued the case with a scalpel for dissection and no further issues occurred. Surgeon used the plasmablade again after the new st. Jude pacemaker was implanted and activation of the plasmablade did not impact pacemaker functionality. St. Jude victory pacemaker that was replaced was at the eri (elective replacement interval). St jude has released a document stating that electrosurgery may have an impact to the functionality of older model st. Jude pacemakers and recommends no electrosurgery devices to be used. Reference link: http://professional. Sjm. Com/professional/resources/product-p erformance/pacemaker-012914-communication/physician-communication
Patient Sequence No: 1, Text Type: D, B5
[12259732]
(b)(4). Eval method/results/conclusion: generator still in use and facility not returning for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813060]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00071 |
| MDR Report Key | 4029648 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-22 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-24 |
| Date Mfgr Received | 2014-07-24 |
| Date Added to Maude | 2014-08-22 |
| 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 | 3 |
| Event Location | 3 |
| 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 | GENERATOR PULSAR II |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-08-22 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-08-22 |