MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation (puerto Rico, Llc).
[185939883]
Date of event is estimated. 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
[185939884]
Related manufacturer reference number: 3006705815-2020-01491. Related manufacturer reference number: 3006705815-2020-01493. It was reported the patient is not receiving effective stimulation. Surgical intervention may take please at later date to address the issue.
Patient Sequence No: 1, Text Type: D, B5
[189106139]
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
| Report Number | 3006705815-2020-01492 |
| MDR Report Key | 9907757 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-09-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
| Manufacturer Street | LOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK |
| Manufacturer City | ARECIBO PR 00612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCTRODE LEAD KIT, 60CM LENGTH |
| Generic Name | SCS LEAD |
| Product Code | LGW |
| Date Received | 2020-03-31 |
| Model Number | 3186 |
| Catalog Number | 3186 |
| Lot Number | A000065227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
| Manufacturer Address | LOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK ARECIBO PR 00612 US 00612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |