MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2013-08-22 for CSF-VENTRICULAR RESERVOIR, SIDE INLET CONNECTOR, 18 MM 44102 manufactured by Medtronic Neurosurgery.
[3708588]
It was reported to medtronic neurosurgery that the ventricular catheter included with the csf-ventricular reservoir tore when it was being placed in the patient. Another product was pulled from the shelf to complete the surgery, and there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[11021681]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[91248065]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2013-00283 |
| MDR Report Key | 3304295 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2013-08-22 |
| Date of Report | 2013-07-24 |
| Date of Event | 2013-07-24 |
| Date Mfgr Received | 2013-07-24 |
| Device Manufacturer Date | 2009-06-24 |
| Date Added to Maude | 2013-11-19 |
| 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 | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CSF-VENTRICULAR RESERVOIR, SIDE INLET CONNECTOR, 18 MM |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2013-08-22 |
| Catalog Number | 44102 |
| Lot Number | C47015 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-22 |