MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation (puerto Rico, Llc).
[185935220]
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
[185935221]
Related manufacturer reference number: 3006705815-2020-01489. It was reported that both of the patient's thoracic leads migrated. The issue was confirmed via x-rays. As a result, the patient underwent surgical intervention wherein both existing leads were explanted and replaced to address the issue. Effective therapy was established postoperatively.
Patient Sequence No: 1, Text Type: D, B5
[188917431]
Based on the information provided, a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006705815-2020-01490 |
| MDR Report Key | 9907681 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-12-21 |
| 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 | A000049921 |
| Device Expiration Date | 2019-12-21 |
| 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 |