MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-24 for LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH 1772 manufactured by St. Jude Medical - Neuromodulation.
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(b)(4). Sjm has limited information related to the patient? S medical history and is unable to form an opinion as to the relevancy of the patient? S history to the event reported. Sjm defers to the patient? S physician regarding medical history. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
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Device 3 of 3. Reference mfr report #: 1627487-2015-07562 and 1627487-2015-07563.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2015-07564 |
| MDR Report Key | 5101431 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-24 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-08-28 |
| Date Mfgr Received | 2015-08-28 |
| Device Manufacturer Date | 2014-12-12 |
| Date Added to Maude | 2015-09-24 |
| 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 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 | LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH |
| Generic Name | SCS EPIDUCER |
| Product Code | LHG |
| Date Received | 2015-09-24 |
| Model Number | 1772 |
| Lot Number | 4912592 |
| Device Expiration Date | 2016-12-28 |
| 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 | 2015-09-24 |