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, 19CM (7.5 IN), 1 EACH 1773 manufactured by St. Jude Medical - Neuromodulation.
[26686172]
(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. Udi (di): (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26686173]
Device 2 of 3. Reference mfr report #: 1627487-2015-07562 and 1627487-2015-07564.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1627487-2015-07563 |
MDR Report Key | 5101426 |
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 | 2015-05-06 |
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, 19CM (7.5 IN), 1 EACH |
Generic Name | SCS EPIDUCER |
Product Code | LHG |
Date Received | 2015-09-24 |
Model Number | 1773 |
Lot Number | 5077236 |
Device Expiration Date | 2015-11-30 |
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 |