MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for KENDALL DISPOSABLE LEAD SET 33136T manufactured by Cardinal / Covidien.
[82821489]
The disposable leads from kendall on a pt had a defect and it was showing a posterior hemi block, ekg was performed showing sinus rhythm with first degree block as per previous ekg done in er. Leads were changed and no harm was caused. Five lead dual connect disposable lead set. Date of use (b)(6) 2017. Diagnosis or reason for use: elevated hr 140 range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071569 |
| MDR Report Key | 6794088 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-07-30 |
| Date Added to Maude | 2017-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KENDALL DISPOSABLE LEAD SET |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-08-07 |
| Model Number | 33136T |
| Catalog Number | 33136T |
| Lot Number | 289267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL / COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |