MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[185495165]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185495166]
Information was received from a patient regarding their implantable neurostimulator (ins). Information was reported that the patient stated on (b)(6) 2020 she had a bladder ins implanted on her right side. The patient thinks the bladder ins has caused issues with her spinal cord stimulator (scs) device. The patient stated when both devices are on her nerve pain had increased and doubled. No further complications were reported. No additional patient symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
[187335947]
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. Please refer to regulatory report 3004209178-2020-06475 for the device product id: 3058, sn: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2020-06351 |
| MDR Report Key | 9897153 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2020-01-21 |
| 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 |
| 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 |