MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[186133403]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186133404]
On 2020-mar-19 (b)(4) (hcp): information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor. It was reported by the mri technician that there was a power on reset (por) message when they attempted to turn the patient? S stimulation off for an mri. The caller mentioned that they had spoken with a manufacturer representative (rep) that day but the caller indicated that the rep had been unable to meet with the patient due to covid-19. The caller noted that they (or the patient) did think that the patient had been around any emi recently. There were no symptoms reported and the caller was redirected to follow up with the managing physician as the por meant that the stimulation was off but the message could only be cleared with a clinician programmer. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06232 |
| MDR Report Key | 9887195 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2017-04-04 |
| 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 | 2018-09-28 |
| 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 | 2020-03-26 |