MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for INFINITY? 7 IMPLANTABLE PULSE GENERATOR 6662 manufactured by St. Jude Medical - Neuromodulation.
[185250716]
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
[185250717]
It was reported that the patient experienced inflammation at the ipg site and signs of infection following the permanent scs implant procedure. As such, surgical intervention took place on (b)(6) 2020 wherein the ipg site was disinfected to prevent infection. Additionally, the patient was treated with injection and medication.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1627487-2020-03340 |
MDR Report Key | 9888459 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-03-27 |
Date of Report | 2020-03-27 |
Date of Event | 2020-03-04 |
Date Mfgr Received | 2020-03-04 |
Device Manufacturer Date | 2019-09-09 |
Date Added to Maude | 2020-03-27 |
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 | INFINITY? 7 IMPLANTABLE PULSE GENERATOR |
Generic Name | DBS IPG |
Product Code | MHY |
Date Received | 2020-03-27 |
Model Number | 6662 |
Catalog Number | 6662 |
Lot Number | 7163746 |
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 | 2020-03-27 |