MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[185731356]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185731357]
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor. It was reported that the patient? S programmer was not working and? It kept getting worse?. They could not clarify what was wrong with the programmer. Tutorials for programmer use were sent to the patient. During the report, the patient was able to connect to the ins right away. After connecting, it showed that the stimulation was off. The patient was able to turn the stimulation back on and could feel the stimulation. Additional information was received from the consumer on (b)(6) 2020. In response to the inquiry of what the circumstances were that led to the stimulation being off and if a cause had been determined, the patient replied? No,? That it was not working properly, or as they stated before, the doctor who tested the device every year said that it hadn't been working, not even when it was on. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
[186454270]
Previously reported event date does not apply. The event date is currently unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2020-06402 |
| MDR Report Key | 9900411 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-10-22 |
| 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 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 | 2020-03-30 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| Device Expiration Date | 2019-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-30 |