MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-02 for 44410 manufactured by Medtronic Neurosurgery.
[19937945]
(b) (4). The device has not been returned to the mfr.
Patient Sequence No: 1, Text Type: N, H10
[19962101]
The customer is reporting on the retention of a foreign object. A 3. 5 cm piece of broken silicone catheter tip was retained in the pt's lumbar area. The anesthesiologist placed a medtronic csf lumboperitoneal catheter system using a 14g touly needle to find the subarachnoid space. A drain catheter was advanced into the needle. Resistance was met at what appeared to be the end of the needle, but we couldn't tell because there were no markings. The needle was removed. No csf was noted in the drain. The anesthesiologist attempted to place a needle adapter into the end of the catheter and noticed there were drainage holes. At this point, it was realized the catheter was reversed. The silicone catheter was removed gently, but snapped off at skin level. A small vertical incision was made and the area explored with a hemostat, but no catheter tip was found. The surgeon then explored the areas further without finding the tip, and then closed the area with nylon sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2009-00133 |
| MDR Report Key | 1482853 |
| Report Source | 05 |
| Date Received | 2009-07-02 |
| Date of Report | 2009-06-04 |
| Date of Event | 2009-04-27 |
| Device Manufacturer Date | 2013-04-30 |
| Date Added to Maude | 2009-10-14 |
| 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 | 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 |
| Generic Name | NONE |
| Product Code | LKG |
| Date Received | 2009-07-02 |
| Model Number | NA |
| Catalog Number | 44410 |
| Lot Number | C25083 |
| ID Number | NA |
| Device Expiration Date | 2008-05-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117550 US 93117 5500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-02 |