MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-31 for 5487L manufactured by Medtronic, Inc..
[109686210]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[109686231]
It was reported that while in use the external pulse generator lost capture and it was attributed to a loose connection between the lead and the generator. The temporary external pulse generator was replaced by a permanent pulse generator. Following the loss of capture it was noted that the patient had to be externally paced. The lead (cable) is expected to be returned. It was noted that the patient was alive with no injury and no further patient complication have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[110998191]
Product analysis: analysis did not confirm the customer comment of loose connection, the cable passed its visual inspection with no anomalies found and all continuity tests were okay. No intermittent or shorted connections were found and the connector held the cable firmly. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2018-01005 |
| MDR Report Key | 7557725 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-31 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-26 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2018-01-12 |
| Date Added to Maude | 2018-05-31 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-05-31 |
| Model Number | 5487L |
| Catalog Number | 5487L |
| Lot Number | 647460001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-05-31 |