MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B 6371 manufactured by St. Jude Medical - Neuromodulation.
[185144995]
The results/method and conclusion codes along with investigation results will be provided on the final report.
Patient Sequence No: 1, Text Type: N, H10
[185144996]
Related manufacturer report 1627487-2020-03244; related manufacturer report 1627487-2020-03245. It was reported that high impedance issue was observed, and the implantable pulse generator (ipg) was unable to establish communication with the clinician programmer. As a result, the ipg and the two extensions was explanted and a new ipg and extensions were implanted to resolve the issue. There were no complications during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03246 |
| MDR Report Key | 9884759 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-01-18 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 FLEX EXTN KIT, 50CM, B |
| Generic Name | DBS EXTENSION |
| Product Code | MHY |
| Date Received | 2020-03-26 |
| Model Number | 6371 |
| Catalog Number | 6371 |
| Lot Number | 6280866 |
| Device Expiration Date | 2020-01-18 |
| 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 | 2020-03-26 |