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 2018-12-27 for PROCLAIM 5 ELITE 3660 manufactured by St. Jude Medical - Neuromodulation (puerto Rico, Llc).
[131581142]
Device 1 of 5. Reference mfr. Report#: 3006705815-2018-03460, 1627487-2018-13408, 1627487-2018-13407, 3006705815-2018-03458. It was reported the patient? S entire scs system was removed due to a possible infection. The site of the infection is unknown. Postoperatively, the patient has completed antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006705815-2018-03457 |
| MDR Report Key | 8201311 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2018-12-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 (PUERTO RICO, LLC) |
| Manufacturer Street | LOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK |
| Manufacturer City | ARECIBO PR 00612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLAIM 5 ELITE |
| Generic Name | SCS IPG |
| Product Code | LGW |
| Date Received | 2018-12-27 |
| Model Number | 3660 |
| Lot Number | A000064341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
| Manufacturer Address | LOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK ARECIBO PR 00612 US 00612 |
| Brand Name | PROCLAIM 5 ELITE |
| Generic Name | SCS IPG |
| Product Code | LSW |
| Date Received | 2018-12-27 |
| Model Number | 3660 |
| Lot Number | A000064341 |
| 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 (PUERTO RICO, LLC) |
| Manufacturer Address | LOT A INTERIOR - #2 STREET KM 67.5 SANTANA INDUSTRIAL PARK ARECIBO PR 00612 US 00612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-27 |