MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-10-05 for STRATA SNAP SHUNT ASSEMBLY, REGULAR 27605 manufactured by Medtronic Neurosurgery.
[744580]
It was reported that the product was explanted because it was not functioning.
Patient Sequence No: 1, Text Type: D, B5
[7947098]
The product was not available for return to the mfr. Therefore an eval of the device performance was not possible. A review of the mfg records showed no anomalies. All our products are 100% tested at the time of manufacture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2004-00138 |
| MDR Report Key | 977352 |
| Report Source | 05,06 |
| Date Received | 2004-10-05 |
| Date of Report | 2004-09-16 |
| Date of Event | 2004-06-29 |
| Date Facility Aware | 2004-06-29 |
| Report Date | 2004-09-28 |
| Date Reported to FDA | 2004-08-12 |
| Date Reported to Mfgr | 2004-08-12 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2008-01-11 |
| 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 DR |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059681546 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR |
| Manufacturer City | GOLETA CA 93117550 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 5500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATA SNAP SHUNT ASSEMBLY, REGULAR |
| Generic Name | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS |
| Product Code | JYG |
| Date Received | 2004-10-05 |
| Model Number | NA |
| Catalog Number | 27605 |
| Lot Number | A33796 |
| ID Number | NA |
| Device Expiration Date | 2006-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 945557 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 931175500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-05 |