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 IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic, Inc..
[184055654]
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_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_unknown_lead, lot#: unknown, product type: lead. Product id: neu_unknown_lead, lot#: unknown, product type: lead. Product id: neu_unknown_lead, lot#: unknown, product type: lead. Product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ens_stimulator, lot# unknown, product type: external neurostimulator. Product id: neu_ens_stimulator, lot# unknown, product type: external neurostimulator. Product id: neu_unknown, lot#: unknown, product type: unknown. Product id: neu_ens_stimulator, lot#: unknown, product type: external neurostimulator. Product id: neu_ins_stimulator, serial/lot #: unknown. Product id: neu_ins_stimulator, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. Product id: neu_unknown_lead, serial/lot #: unknown. 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
[184055655]
Zegrea, a. , kirss, j. , pinta, t. , rautio, t. , varpe, p. , kairaluoma, m. , aho, m. , bockelman, c. , lavonius, m. Outcomes of sacral neuromodulation for chronic pelvic pain: a finnish national multicenter study. Tech coloproctol. 2020. Doi: 10. 1007/s10151-020-02148-2. Summary: the aim of this study was to report the outcomes of sacral neuromodulation (snm) in chronic pelvic pain (cpp) patients in the finnish national cohort. This was a register-based retrospective study, involving all the centers that provide snm treatment in finland. The data of all patients treated with snm for cpp were gathered from oulu-, turku-, tampere- and helsinki university hospitals, as well as jyv? Skyl? And sein? Joki central hospitals. All patients who had been tested for snm implantation prior to april 2017 were included in the study. A total of 51 patients were selected for snm treatment due to cpp from 2004 until 2017. The mean follow-up time was 13. 8 months (sd 22. 9 months). A total of 28 patients (57%) advanced from testing to permanent stimulator implantation. There were 21 patients (41%) who had a working modulator implanted at the end of follow-up. Patients with endometriosis related pain had a significantly higher permanent implantation rate than the overall implantation rate (88% vs. 57%; p = 0. 01). The endometriosis patients also had a higher overall success rate by the end of the follow-up (75% vs. 41%; p = 0. 026) snm may be a viable treatment option for patients with cpp due to endometriosis. Further research on snm treatment for endometriosis patients with refractory cpp is needed. Reported events: 4 patients with chronic pain experienced a loss of effect and had their device removed. One patient with chronic pain experienced pain and had their device removed. One patient with chronic pain experienced an infection and had their device removed. During the test phase one patient experienced an infection that led to a further procedure. During the test phase one patient experienced an infection. During the test phase 3 patients experienced site pain that led to a further procedure. During the test phase a patient? S electrode was replaced due to cable dislodgement. During the test phase a patient? S electrode was replaced due to operational site pain. No specific device information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00424 |
| MDR Report Key | 9782556 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-21 |
| 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 |
| 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 | MEDTRONIC, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | INTESTINAL STIMULATOR |
| Product Code | LNQ |
| Date Received | 2020-03-03 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |