MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-03-27 for MEDTRONIC REUSABLE EXTENSION CABLE 53912 manufactured by Oscor Inc..
[70969902]
This report is part of an internal retrospective review of complaints, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained. As part of the detailed review, this event has been determined to be reportable. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[70969903]
It was reported that while a patient was connected to a external pulse generator (epg), non-capture was noted on the monitor. Output was increased to the maximum setting with no capture. The batteries in the epg were changed and intermittent pacing was noted with manipulation of the cable. The epg was changed out for a different one and capture was noted with return of pulse and blood pressure. Upon examination of the epg extension cable, it was noted that the cable was broken beneath the connection on the proximal black pin. The patient status returned to stable condition after resumption of pacing. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00028 |
| MDR Report Key | 6437717 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-27 |
| Date of Event | 2014-07-02 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2017-03-27 |
| 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 | MS DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC REUSABLE EXTENSION CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-03-27 |
| Model Number | 53912 |
| Catalog Number | 53912 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5391 | 1. Hospitalization; 2. Required No Informationntervention | 2017-03-27 |