MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-02-24 for PENA MUSCLE STIMULATOR PROBE (NOT STERILE) PS-2P manufactured by Integra Neurosciences Implants S.a..
[4675736]
The fifth report of eight from the same facility involving pena probe. Cross reference with mfr. Report 9612007-2014-00003. A report was received from a children's hospital tha the pena probe stopped/didn't work. The consultant surgeon cut the cable and exposed the inner cabling which appeared to be oxidized. The probe was in contact with a patient (age of the patient is not available). There was a delay while the staff located another probe to use. There was no injury involved as a result of the delay.
Patient Sequence No: 1, Text Type: D, B5
[11929714]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2014-00006 |
| MDR Report Key | 3902051 |
| Report Source | 01,05 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-01-29 |
| Date Mfgr Received | 2014-01-24 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENA MUSCLE STIMULATOR PROBE (NOT STERILE) |
| Generic Name | PENA MUSCLE STIMULATOR PROBE |
| Product Code | IPF |
| Date Received | 2014-02-24 |
| Catalog Number | PS-2P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-02-24 |