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.
[185916229]
The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[185916230]
It was reported the patient's implanted scs lead migrated. Consequently, surgical was taken, however, during the procedure the physician decided the epidural space was too tight to add a lead. Nothing was implanted or explanted. No complications reported.
Patient Sequence No: 1, Text Type: D, B5
[188436210]
The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-03440 |
| MDR Report Key | 9907843 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| 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 | 2011-04-12 |
| 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 |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| 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 |
| Lot Number | 3365362 |
| Device Expiration Date | 2013-04-28 |
| 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 |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |