MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-22 for VICTORY XL DR 5816 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[184387648]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[184387649]
It was reported that when the patient presented for device replacement due to normal eri, required programming changes were made to the device as patient did not have any intrinsic rhythm. During the procedure, the physician used electrosurgery when the electrocardiogram paused. Device interrogation revealed sane programmed setting. The physician proceeded with electrosurgery again when the device was found to be in backup vvi mode. The device was replaced, and procedure was completed without any complications. The patient did not experience any adverse consequences and was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02092 |
| MDR Report Key | 9863717 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-22 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2010-10-05 |
| Date Added to Maude | 2020-03-22 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICTORY XL DR |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | DXY |
| Date Received | 2020-03-22 |
| Model Number | 5816 |
| Catalog Number | 5816 |
| Lot Number | 3224548 |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-22 |