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..
[185904924]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185904925]
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim. It was reported that the patient has problem with urinary retention. Currently having a return of symptoms. The patient is a self-induced catheter. The patient has irritable bowel syndrome (ibs) affecting bowels and having constipation. The patient took merylax to help with her constipation. The patient is getting botox injection tomorrow. First botox injection in 9 months. The patient did take five doses of myralex the other day the patient was told to turn off stim for a couple hours while taking myralax. The patient was advised to turn it off 2-3 hours max. After bowel lets go, then turn it back on and could hear her bowel sounds. Now she is hearing reduce sounds again in her stomach. The patient is seeing her urologist tomorrow. Her abdomen is uncomfortable. Been able to pass, took 2-3 doses an hours or two apart. The patient wanted to know if she can turn off the device again. It was recommended that they follow up with their healthcare professional. The patient said she is going to shut off the device. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06225 |
| MDR Report Key | 9886113 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2015-11-14 |
| 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 | 2017-05-14 |
| 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. Other | 2020-03-26 |