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 2020-02-21 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic, Inc..
[180865101]
Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot#: unknown, product type: lead. 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_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. 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_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. 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_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. 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_ins_stimulator, lot#: unknown, product type: implantable neurostimulator. 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_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
[180865102]
Summary: the erp in the pelvic health bu and the patients were treated using interstim devices for oab. The study had a cross-over design with a total of n=34 patients, so you will see 3 columns in the attached table: total, contralateral then bilateral (cross-over arm 1) bilateral then contralateral (cross-over arm 2). Reported event: one patient (2. 9) reported an occurrence of an infection in the path of the electrode during the visit 3 follow up. No specific device information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00345 |
| MDR Report Key | 9741788 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-21 |
| 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 | 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 | 2020-02-21 |
| 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. Other | 2020-02-21 |