MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-04 for PULSAR 2 GENERATOR PS100-102 manufactured by Medtronic Advanced Energy.
[4634055]
During a pacemaker generator exchange with a pacemaker dependent patient the plasmablade was activated and the pacing output of the pacemaker and the patient? S heart rate dropped to 30 bpm. When plasmablade was deactivated the pacemaker output and the patient's heart rate remained low for 10-14 more seconds before increasing back to a normal rate. A temporary pacemaker was hooked up and the case continued without further incident. Pacemaker being replaced was at the eri (elective replacement interval = near end of battery life). 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 7/24/2014.
Patient Sequence No: 1, Text Type: D, B5
[12070651]
Product event (b)(4) evaluation method, result: generator not returned; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00057 |
| MDR Report Key | 3975721 |
| Report Source | 06,07 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-06-03 |
| Date Mfgr Received | 2014-06-03 |
| Date Added to Maude | 2014-08-04 |
| 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 | 2014-08-04 |
| Model Number | PS100-102 |
| Catalog Number | PS100-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-04 |