MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-10 for 4-CH DBS LEAD, 40 CM CONTACT 1.5, SPACE 1.5 6145 manufactured by St. Jude Medical - Neuromodulation.
[2865936]
Device 1 of 2. Reference mfr report: 1627487-2012-10308. The pt ((b)(6)) received a dbs system which includes a dbs lead and dbs lead extension. It was reported high impedance values are present when stimulation is increased. It was determined that surgical intervention is necessary to interrogate the dbs system. Surgical intervention is pending pt approval. If approved, surgical intervention will be undertaken at a later date to resolve the issue.
Patient Sequence No: 1, Text Type: D, B5
[10173402]
This device is not approved for sale in the usa, but is similar to a usa marketed/approved device. Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported. Sjm defers to the pt's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2012-10307 |
| MDR Report Key | 2696687 |
| Report Source | 01,07 |
| Date Received | 2012-08-10 |
| Date of Report | 2012-07-20 |
| Date of Event | 2012-07-20 |
| Date Mfgr Received | 2012-07-20 |
| Date Added to Maude | 2012-08-15 |
| 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 | 0 |
| Manufacturer Contact | KARIN BECHLER |
| Manufacturer Street | 6901 PRESTON RD. |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723092511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4-CH DBS LEAD, 40 CM CONTACT 1.5, SPACE 1.5 |
| Generic Name | DBS LEAD |
| Product Code | GYZ |
| Date Received | 2012-08-10 |
| Model Number | 6145 |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2012-08-10 |