MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-12-01 for SOLETRA 7426 NA manufactured by Medtronic Puerto Rico Operations Co.
[16203277]
On 11/06/2008 the explanted devices have been returned to the mfr for analysis, which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[16254421]
The deep brain stimulator, lead and extension were explanted due to infection (causative organism unk). Pt symptoms included redness and swelling at the device implant site of the chest, neck and head. The pt outcome was not reported. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2008-07848 |
| MDR Report Key | 1248104 |
| Report Source | 05,07 |
| Date Received | 2008-12-01 |
| Date of Report | 2008-11-03 |
| Date of Event | 2008-10-31 |
| Date Mfgr Received | 2008-11-03 |
| Device Manufacturer Date | 2008-08-12 |
| Date Added to Maude | 2008-12-05 |
| 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 | SOLETRA |
| Product Code | MYH |
| Date Received | 2008-12-01 |
| Returned To Mfg | 2008-11-06 |
| Model Number | 7426 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2010-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1303838 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-01 |