MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-05-04 for CSF VENTRICULAR PORT, 16 MM, SIDE INLET 44010 manufactured by Medtronic Neurosurgery.
[107450538]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107450539]
It was reported that during the implant procedure, it was found that there was a fracture in the reservoir. The port was replaced and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[112876537]
Patient weight provided. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[112876538]
Additional information received reported the cause of the reservoir fracture was unknown.
Patient Sequence No: 1, Text Type: D, B5
[118563203]
The returned port did not meet the requirements for leak testing due to a tear in the top of the reservoir. It is unknown how or when the damage occurred. There was also proteinaceous debris observed within the interior and exterior of the port. The returned catheter was patent and met the requirements for leak testing. The instructions for use (ifu) that accompany the device caution that? Improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.? The ifu also caution that? Care should be taken in handling the valves as silicone has a low cut and tear resistance.? All ports and catheters are 100% inspected at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2018-00237 |
| MDR Report Key | 7487979 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-04 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2017-07-17 |
| Date Added to Maude | 2018-05-04 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| 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 PORT, 16 MM, SIDE INLET |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-08-10 |
| Model Number | 44010 |
| Catalog Number | 44010 |
| Lot Number | E34990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-04 |