MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-03 for EXTERNAL NEUROSTIMULATOR NEU_ENS_STIMULATOR manufactured by Rice Creek Mfg.
[182724472]
Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead. Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182724473]
Melling, n. , scognamiglio, p. , teller, s. , izbicki, j. R. , dreimann, m. , perez, d. First in literature intra-neuronal sacral nerve stimulation for fecal incontinence after robotic assisted en-bloc sacrectomy with transection of nerve roots. World neurosurg. 2020. Doi: 10. 1016/j. Wneu. 2019. 12. 173. Summary: en-bloc sacrectomy is the treatment of choice for patients affected by sacral chordoma. It is a radical surgical procedure, which has to face the problem of handling fragile anatomic structures, such as the internal iliac vessels and the sacral nerve roots, with the risk of causing bowel, bladder, and sexual dysfunction. The combined anterior-posterior approach allows for a safer dissection of the tumor from the mesorectal fascia than the mere posterior approach, especially for tumors extending proximally to s3. Robotic surgery can improve the safety of the procedure. Sacral nerve stimulation is an accepted therapeutic option for fecal incontinence and may be used to treat postoperative incontinence. We report on a patient affected by sacral chordoma with en-bloc sacrectomy preceded by a robotic-assisted dissection of the mesorectal fascia and on managing the postoperative fecal incontinence by implanting a sacral nerve stimulator on the first postoperative day. To our knowledge this is the first such procedure in the literature. From our experience, a robotic anterior approach increases safety for the organs in the pelvis when performing a sacrectomy. Moreover, a sacral nerve stimulator should be considered to manage neurologic complications following transection of nerve roots after sacrectomy. Reported events: a (b)(6)-year-old male patient developed an infection of the urinary tract, which was successfully treated with antibiotics and a minor surgical site infection of the midline incision between the advancement flaps, which was treated conservatively. A (b)(6)-year-old male patient was fully satisfied with the anal and urinary sphincter function, and because no adjuvant treatment was intended, the stimulator was internalized on the 18th postoperative day (medtronic 3058 (b)(4)) and the patient was discharged the following day. The follow-up 2 months postoperatively showed a surgical site infection at the incision for the left-sided electrode, which was managed by removal of this electrode. At the last follow-up, after 4 months, the patient reported on a satisfactory course with no residual fecal or urinary incontinence. No specific device information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2020-00082 |
| MDR Report Key | 9779958 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTERNAL NEUROSTIMULATOR |
| Generic Name | INTESTINAL STIMULATOR |
| Product Code | LNQ |
| Date Received | 2020-03-03 |
| Model Number | NEU_ENS_STIMULATOR |
| Catalog Number | NEU_ENS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |