MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-09-26 for MEDTRONIC 43418 manufactured by Unknown.
[17562353]
Pt had an indwelling ventriculocardiac shunt. She presented for vomiting and intermittent lethargy. Eval included a shuntogram and ct. The images revealed evidence of a fracture of the cardiac cath just proximal to it's entrance into the venous system. The shunt was externalized and interventional radiology was required to obtain the piece of broken off cath. Pt a few days later had to have a shunt revision with remineralization into the peritoneal cavity. Required a right upper quadrant laparotomy with placement of the peritoneal portion of the vp shunt. Other remarks: obtaining off site records to help identify the lot #, will amend report and resend to fda and will forward to medtronic at that time. Working with (b)(6) at medtronic, who will assist in assuring correct address obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2768117 |
| MDR Report Key | 2768117 |
| Report Source | 99 |
| Date Received | 2012-09-26 |
| Date of Report | 2012-09-26 |
| Date of Event | 2012-09-16 |
| Date Facility Aware | 2012-09-16 |
| Report Date | 2012-09-26 |
| Date Reported to FDA | 2012-09-26 |
| Date Added to Maude | 2012-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC |
| Generic Name | VENTRICULOCARDIAC CATH |
| Product Code | OEX |
| Date Received | 2012-09-26 |
| Model Number | 43418 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2012-09-26 |