MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-09-25 for MAE UNKNOWN PEAK PULSAR GENERATOR MAE UNK PEAK GEN manufactured by Medtronic Advanced Energy.
[15122878]
During a generator changeout procedure where a plasmablade device was utilized to clear the pocket of scar tissue surrounding the leads and pacemaker, the physician noticed "nicks" in the outer insulation of both the atrial and right ventricular leads. The physician was not sure if the insulation issues were pre-existing or were caused by the use of electrocautery. The leads were at least partially explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15338967]
Product event (b)(4). Method, results, conclusion: product requested for return but not received by manufacturer for inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103813206]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00088 |
| MDR Report Key | 4116706 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-09-25 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2014-08-06 |
| Date Added to Maude | 2014-10-03 |
| 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 |
| 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 | MAE UNKNOWN PEAK PULSAR GENERATOR |
| Generic Name | GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER |
| Product Code | MUL |
| Date Received | 2014-09-25 |
| 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 |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-09-25 |