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 2020-03-24 for KIT IMPLANTABLE SLIM TIP LEAD, 50CM MN10450-50A manufactured by St. Jude Medical - Neuromodulation.
[184801178]
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
[184801179]
Related manufacturer report number 1627487-2020-03223. It was reported that during the implant procedure, the patient experienced a csf leak. Patient has not had any symptoms from the csf leak. The system is currently working properly and patient has effective therapy.
Patient Sequence No: 1, Text Type: D, B5
[187820541]
During processing of this incident, attempts were made to obtain complete patient information. Further information was requested but not received. Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[187820542]
Additional information revealed that the patient underwent a blood patch and was hospitalized for a few days. The csf leak has reportedly resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-03222 |
| MDR Report Key | 9873976 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-10-08 |
| Date Added to Maude | 2020-03-24 |
| 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 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM |
| Generic Name | DRG SLIM TIP LEAD |
| Product Code | PMP |
| Date Received | 2020-03-24 |
| Model Number | MN10450-50A |
| Catalog Number | MN10450-50A |
| Lot Number | 7161025 |
| 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 | 2020-03-24 |