MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for NIM? EMG ELECTRODE 8227410 manufactured by Medtronic Xomed Inc..
[54030544]
The product analysis indicates that part number 8227410 (paired electrodes) from lot number 0211358568 were received. The paired electrodes were opened and removed from their pouch. The ground and stimulation return electrodes were still in the sealed pouch and therefore not tested. A microscope and multimeter were used for testing. When compared to the assembly drawing, visually there was no external damage to the electrodes which would have resulted in the reported event, which likely rules out mishandling. When compared to the assembly drawing for paired subdermal electrodes, end to end resistance for each side of the paired electrodes shall be <2. 0 ohms and infinite ohms between needle tips [no short circuit]. The actual measurements of the red paired were as follows - both poles measured 1. 5 ohms with no short circuit between poles (in specification). The actual measurements of the blue paired were as follows - both poles measured 1. 6 ohms however measuring from needle to needle showed 0. 4 ohms which indicates a short circuit between poles (out of specification) and is likely to have resulted in the intermittent behavior that the customer experienced.
Patient Sequence No: 1, Text Type: N, H10
[54030547]
During surgery preparation the electrodes cannot steadily (consistently) detect muscles' response. When connected, this pair of electrodes intermittently lost response. The surgeon replaced this pair of electrodes with a new pair and this solved the problem. The event caused an approximately 15-minutes delay and did not cause any harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[102576114]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00272 |
| MDR Report Key | 5906891 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-01 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2016-08-26 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NIM? EMG ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH |
| Product Code | IKT |
| Date Received | 2016-08-26 |
| Returned To Mfg | 2016-08-15 |
| Model Number | 8227410 |
| Catalog Number | 8227410 |
| Lot Number | 0211358568 |
| 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 XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-26 |