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 2018-12-20 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation.
[131124477]
Device 1 of 2. Reference mfr. Report#: 1627487-2018-13248. It was reported during an elective scs system upgrade procedure on (b)(6) 2018, inter-op testing revealed the patient? S leads showed impedance issues. As a result, the patient? S leads were explanted and replaced. Effective therapy was restored following the procedure and the issue is resolved.
Patient Sequence No: 1, Text Type: D, B5
[134753988]
Device 1 of 2. Reference mfr. Report#: 1627487-2018-13248.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2018-13245 |
| MDR Report Key | 8187444 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-20 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2015-03-18 |
| Date Added to Maude | 2018-12-20 |
| 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 | 2018-12-20 |
| Model Number | 3186 |
| Lot Number | 5018286 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Brand Name | OCTRODE LEAD KIT, 60CM LENGTH |
| Generic Name | SCS LEAD |
| Product Code | LSW |
| Date Received | 2018-12-20 |
| Model Number | 3186 |
| Lot Number | 5018286 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-12-20 |