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 2018-08-07 for 5487 manufactured by Medtronic, Inc..
[116232657]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[116232658]
It was reported that, while being paced with an external pulse generator (epg) during a device replacement procedure, the patient went into asystole, with loss of capture and oversensing exhibited. It was noted that the issue arose when the replacement lead and patient cable were being taped down. The patient was paced with an external defibrillator and the connection between the patient cable and lead was adjusted, but the issue persisted. The lead was connected to a pacing analyzer and shown to function normally. The patient cable was replaced, and the patient was able to be paced with the epg and lead without issue. It was noted that the implanting physician attributed the issue to the connector block of the patient cable. The cable was returned for analysis. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[126403958]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2018-01431 |
| MDR Report Key | 7756658 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-07 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-07 |
| 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 | 2018-08-07 |
| Returned To Mfg | 2018-07-20 |
| Model Number | 5487 |
| Catalog Number | 5487 |
| Lot Number | 648490001 |
| 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, 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 | 2018-08-07 |