MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-12-20 for SHUNT TUNNELER 990010 manufactured by Integra Neurosciences Implants S.a..
[4342807]
It was reported that the tunneler was too soft and too complicated to guide. The product was in contact with the patient. There was no patient injury or death alleged. This event led to an increase in surgery time (exact time not provided). The product was thrown out. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[11640135]
The device involved in the reported incident is not expected to be received for evaluation. The device was discarded by the customer. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2013-00028 |
| MDR Report Key | 3663245 |
| Report Source | 01,05 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-05 |
| Date Mfgr Received | 2013-12-05 |
| Date Added to Maude | 2014-04-16 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUNT TUNNELER |
| Generic Name | VALVE ACCESSORIES |
| Product Code | GYK |
| Date Received | 2013-12-20 |
| Catalog Number | 990010 |
| Lot Number | 172985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Address | SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-20 |