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 2014-08-04 for UNKNOWN PULSAR GENERATOR MAE UNK PEAK GEN manufactured by Medtronic Advanced Energy, Llc.
[21720301]
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). (b)(4), this pe was determined to be reportable. Date of retrospective review (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[22145689]
Product event# (b)(4). Method, results: generator not returned therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103812138]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00059 |
| MDR Report Key | 3975915 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-04 |
| Date of Report | 2013-10-17 |
| Date of Event | 2013-10-09 |
| Date Mfgr Received | 2013-10-17 |
| Date Added to Maude | 2014-08-14 |
| 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 | UNKNOWN PULSAR GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-08-04 |
| Model Number | MAE UNK PEAK GEN |
| Catalog Number | MAE UNK PEAK GEN |
| 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 | 2014-08-04 |