MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[187855982]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187856023]
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that the patient had a return of symptoms ever since they got bronchitis, pneumonia, and fluid in their ears. The patient stated they felt like they were back to square one and it was not doing them any good. The patient wanted to increase stimulation. Syncing with the programmer showed stimulation was on and the patient increased stimulation from 0. 6 to 0. 7 where they felt stimulation comfortably. It was noted that the patient had an appointment scheduled in (b)(6) 2020.? Additional information was received from a consumer indicating that the patient? S ins worked? Some at first? To resolve their symptoms but it had gotten worse since? After (b)(6).? The patient stated they go to the bathroom and can't do nothing but then they leave the bathroom, coughs, and leaks. The patient noted having copd, so they cough a lot and leaks with the coughs. The patient noted being sick all of january, having shots, x-rays, and antibiotics for over a month. The patient noted an appointment with their healthcare provider the following day to go over therapy adjustments and that stimulation was increased to 1. 1 at their last one. The patient was redirected to their healthcare provider. Additional information was received from a consumer. It was reported that they went back on allergy pills and when they woke up their leg was hurting them and it was like they had to pee, but they couldn't pee. It was stated that the same thing happened on the morning of (b)(6) 2020. They also stated that they were leaking an awful lot, and their bladder sill didn't want to empty all the way, and that that had been going on since implant. It was mentioned that they always felt stimulation at 1. 3 so they were assisted with changing to program 6 at 1. 0 where they could feel stimulation. It was recommended that they monitor their symptoms after making the change and follow up with their healthcare provider if not resolved. The patient called back two days later reporting the same issues, with emptying the bladder and leaking, and that the changes made last time had not resolved or improved their symptoms. It was recommended that they follow up with their healthcare provider. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06483 |
| MDR Report Key | 9908885 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| 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 | 2020-03-31 |