MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-21 for PENA MUSCLE STIMULATOR PROBE PS2P manufactured by Integra Neurosciences Implants S.a..
[4980519]
It was reported that the handpiece has no response when it was placed into the box. There was no pt injury. Surgical delay was 10 minutes. Additional info was requested and on (b)(6) 2014, the following was received from the customer: about 10 to 15 minutes into the pena procedure, the incident occurred. The registration nurse plugged the probe into the box as usual and there was no sound; "completely dead silence". The pt was already anesthetized when the problem occurred. There was a replacement product available to be used. There was no pt adverse consequences as a result of the surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[12215780]
To date, the devices involved in the reported incident have not been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612007-2014-00028 |
| MDR Report Key | 4200039 |
| Report Source | 05 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-11-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBOROR NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENA MUSCLE STIMULATOR PROBE |
| Generic Name | PENA STIMULATOR PROBE |
| Product Code | IPF |
| Date Received | 2014-10-21 |
| Catalog Number | PS2P |
| 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 06921 FR 06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-21 |