MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-02 for CSF-NEONATAL RESERVOIR, 8.0CM 24106F manufactured by Medtronic Neurosurgery.
[2053588]
It was reported to medtronic neurosurgery that a revision surgery occurred. According to the report, the back wall of the ventricular reservoir allegedly delaminated from the remainder of the ventricular reservoir system.
Patient Sequence No: 1, Text Type: D, B5
[8987484]
The initial report was for a strata ii valve, small, (b)(4). The returned device was identified as a (b)(6) reservoir, 8. 0cm. The base was separated from the reservoir dome near the system outlet. It is unk how or when this damage occurred. The damage precluded leak testing. A review of the mfg records was not possible as no valid lot number was provided. No impact to the pt was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2011-00124 |
| MDR Report Key | 2118460 |
| Report Source | 05,06 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-04-26 |
| Date Mfgr Received | 2011-05-05 |
| Date Added to Maude | 2011-06-13 |
| 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 | 0 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR. |
| 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-NEONATAL RESERVOIR, 8.0CM |
| Product Code | LKG |
| Date Received | 2011-06-02 |
| Returned To Mfg | 2011-05-12 |
| Catalog Number | 24106F |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-06-02 |