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 2014-11-24 for PULSAR II GENERATOR PS100-102 manufactured by Medtronic Advanced Energy (salient).
[17581279]
While performing a pacemaker generator change-out procedure, the surgeon noticed that a pacemaker lead had been damaged. He was unsure how the damage occurred but, he did not feel that the device had caused the damage. The lead was repaired with a silicone repair kit and the case was completed without further incident. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[17699566]
Product event # (b)(4). Evaluation code (method), (result), (conclusion): generator still in use at facility therefore analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813720]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00117 |
| MDR Report Key | 4273246 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-11-24 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-10-29 |
| Date Mfgr Received | 2014-10-29 |
| Date Added to Maude | 2014-12-03 |
| 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 | PULSAR II GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-11-24 |
| 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 (SALIENT) |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-24 |