MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-09 for 5487 manufactured by Medtronic, Inc..
[62081217]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[62081218]
It was reported before coronary artery bypass surgery, a cable had been placed and plugged in to an external pacemaker. During the procedure, the product showed a dysfunction which caused the patient cardiac arrest. It had been replaced by another of the same lot which presented the same default. The plug between electrodes and wire connection seemed to be deficient. When the connection was moved, sometimes it worked again. During this, the patient received an internal heart massage. Finally the cable was replaced by a different model cable. The cables were returned for analysis. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[67350695]
Product event summary: manufacturer's analysis was unable to confirm the customer comments regarding the cable. During analysis, the cable passed all visual incoming inspection with no anomalies found, and the cable passed all continuity tests with no intermittent or shorted connections found.
Patient Sequence No: 1, Text Type: N, H10
[96126666]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2016-02749 |
| MDR Report Key | 6162043 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-09 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-12-15 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2016-12-09 |
| 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 | 2016-12-09 |
| Returned To Mfg | 2016-11-25 |
| Model Number | 5487 |
| Catalog Number | 5487 |
| Lot Number | 553060001 |
| Device Expiration Date | 2018-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-09 |