MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-03-03 for INTERSTIM II 3058 NA manufactured by Medtronic Puerto Rico Operations Co..
[14870991]
When the patient laid down, she started to feel an overstimulation sensation and stimulation in the wrong location. She felt pain in her vaginal area and thought there was a "light" in the vaginal area as well. The device was turned off, but the pain did not resolve. It was noted that the patient works in janitorial and does a lot of bending and heavy lifting. Further information is being requested at this time.
Patient Sequence No: 1, Text Type: D, B5
[15167985]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2009-01486 |
| MDR Report Key | 1358043 |
| Report Source | 04 |
| Date Received | 2009-03-03 |
| Date of Report | 2009-02-05 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2009-02-05 |
| Device Manufacturer Date | 2008-11-26 |
| Date Added to Maude | 2009-06-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHARLOTTE GASPERLIN |
| Manufacturer Street | 7000 CENTRAL AVE. |
| Manufacturer City | MINNEAPOLIS MN 554323576 |
| Manufacturer Country | US |
| Manufacturer Postal | 554323576 |
| Manufacturer Phone | 7635263952 |
| 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 |
| Product Code | EZM |
| Date Received | 2009-03-03 |
| Model Number | 3058 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2010-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2009-03-03 |