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 2020-03-30 for 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B 6172 manufactured by St. Jude Medical - Neuromodulation.
[186067916]
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
[186067917]
It was reported the patient was not receiving effective stimulation. Images were taken and confirmed that patient? S left lead had migrated. In turn, surgical intervention was undertaken on (b)(6) 2020 wherein patient? S left lead was pulled back and locked down in its intended place. This addressed the issue.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1627487-2020-03384 |
MDR Report Key | 9897278 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-30 |
Date of Report | 2020-03-30 |
Date of Event | 2020-03-09 |
Date Mfgr Received | 2020-03-09 |
Device Manufacturer Date | 2019-01-16 |
Date Added to Maude | 2020-03-30 |
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 | 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B |
Generic Name | DBS LEAD |
Product Code | MHY |
Date Received | 2020-03-30 |
Model Number | 6172 |
Catalog Number | 6172 |
Lot Number | 6809682 |
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 | 2020-03-30 |