MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[185907498]
Concomitant medical products: product id: 3889-28, lot# va1pm2v, implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 07-mar-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185907499]
Information was received from a patient regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor. Patient reported that sometime last year the therapy stopped working and she noticed that when it was reprogrammed, the stimulation would affect her right leg and toe and she also experiences pain in her leg and butt especially when she is sleeping. When asked, patient said that she hasn't had any falls or trauma. Patient said that she has turned stimulation off and the pain goes away when stim is off. Patient has been working with a new doctor and is scheduled for lead revision/replacement around (b)(6) 2020. Patient was redirected to stay in contact with her hcp office. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06219 |
| MDR Report Key | 9885593 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2017-11-20 |
| Date Added to Maude | 2020-03-26 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERSTIM II |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE |
| Product Code | EZW |
| Date Received | 2020-03-26 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| Device Expiration Date | 2019-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |