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.
[26686170]
(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
[26686171]
Device 1 of 3. Reference mfr report #: 1627487-2015-07563 and 1627487-2015-07564. It was reported the patient underwent the permanent implant procedure on (b)(6) 2015. During the surgery, the physician was unable to access the epidural space with three epiducers due to the patient's anatomy. The patient was eventually implanted but the procedure was extended for 45 to 60 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2015-07562 |
| MDR Report Key | 5101420 |
| 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 | 2015-04-23 |
| 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 | 5062579 |
| Device Expiration Date | 2017-03-31 |
| 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 |