MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for LEAD NEU_UNKNOWN_LEAD manufactured by Medtronic Neuromodulation.
[186668673]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186668674]
Information was received from a consumer regarding a patient with an evaluation trial device for gastrointestinal /pelvic floor therapy; the trial began (b)(6) 2020. It was reported the trial patient's granddaughter said that patient started trial last tuesday and is scheduled to have it removed tomorrow, (b)(6) 2020. Caller states that patient reports it has been itchy at lead site since she received it and when caller checked the site noticed that the bandages were moved and a good portion of the lead has been pulled out. Caller said that patient has also noticed that area of stimulation is now more in rectum area. Redirected caller to contact the physician. No further complications were reported or are anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2020-00087 |
| MDR Report Key | 9901269 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 NEUROMODULATION |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS 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 | LEAD |
| Product Code | EZW |
| Date Received | 2020-03-30 |
| Model Number | NEU_UNKNOWN_LEAD |
| Catalog Number | NEU_UNKNOWN_LEAD |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |