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 2020-03-25 for IMPLANTABLE NEUROSTIMULATOR, AU MN20200AU manufactured by St. Jude Medical - Neuromodulation.
[184964861]
The results, method, and conclusion codes along with the investigation results will be provided in final report.
Patient Sequence No: 1, Text Type: N, H10
[184964862]
Related manufacturer reference number: 1627487-2019-12175. Related manufacturer reference number: 1627487-2019-12174. It was reported during follow up the patient underwent surgical intervention to address the ineffective stimulation. During the procedure the patients drg ins was explanted and a new scs system was implanted. The drg leads were left insitu.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1627487-2020-03184 |
MDR Report Key | 9879327 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-25 |
Date of Report | 2020-03-25 |
Date Mfgr Received | 2020-03-04 |
Date Added to Maude | 2020-03-25 |
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 | IMPLANTABLE NEUROSTIMULATOR, AU |
Generic Name | DRG INS |
Product Code | PMP |
Date Received | 2020-03-25 |
Returned To Mfg | 2020-03-16 |
Model Number | MN20200AU |
Catalog Number | MN20200AU |
Lot Number | 4294275 |
Device Expiration Date | 2014-07-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | N |
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 | 2020-03-25 |