MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-25 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St Jude Medical - Neuromodulation.
[20221187]
Device report 1 of 2. Ref mfr report: 1627487-2012-09827. The pt is implanted with two percutaneous leads from different lots. It was reported post-operative the pt experienced pain down her legs and left hip. X-rays confirmed the lead had not moved. The ct scan showed a possible air pocket. The pt was hospitalized and was kept under observation. Further f/u indicated the pt's symptoms were completely resolved by the following day and the pt was subsequently discharged. The pt was programmed and reported effective stimulation coverage.
Patient Sequence No: 1, Text Type: D, B5
[20602585]
Sjm has limited info related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Sjm defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2012-09826 |
| MDR Report Key | 2632338 |
| Report Source | 07 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-08 |
| Date of Event | 2012-06-08 |
| Date Mfgr Received | 2012-06-08 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-06-29 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SANNAH LADIWALLA |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723092522 |
| 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 | MQL |
| Date Received | 2012-06-25 |
| Model Number | 3186 |
| Lot Number | 3463352 |
| Device Expiration Date | 2013-08-01 |
| 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 | PLANO TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-25 |