MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for SJM LOW VOLTAGE DEVICE manufactured by St. Jude Medical, Inc..
[126357354]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[126357355]
During follow-up, the physician was unable to interrogate the device. The physician will continue to monitor the device and a follow-up is anticipated. Additional information has been requested but not yet received. The patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2018-16351 |
| MDR Report Key | 8039586 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-11-05 |
| 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 | ROBERT GREENLEAF |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184932577 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SJM LOW VOLTAGE DEVICE |
| Product Code | DSA |
| Date Received | 2018-11-05 |
| 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. |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-05 |