MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-17 for MEDI-TRACE CADENCE 22550R manufactured by Covidien.
[117450328]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117450329]
The customer states when commissioning the cadence electrodes, there was a contact problem with the connection to the cables.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2018-00017 |
| MDR Report Key | 7792901 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-17 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2018-08-17 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARK DR |
| Manufacturer City | CHICOPEE MA 010221318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 010221318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | MLN |
| Date Received | 2018-08-17 |
| Model Number | 22550R |
| Catalog Number | 22550R |
| Lot Number | 811330X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | DRO |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-08-24 |
| Model Number | 22550R |
| Catalog Number | 22550R |
| Lot Number | 811330X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |