MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-03-27 for MEDTRONIC REUSABLE EXTENSION CABLE 59312 manufactured by Oscor Inc..
[70986668]
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
[70986669]
Over-sensing and over pacing. Temporary pace maker (tpm) lead was inserted in the patient and as soon as tpm lead was connected to the external pacing generator (epg) there was over-sensing initially, later it started under-sensing qrs and paced on t-wave, causing the patient to go into life threatening ventricular arrhythmia. The epg was replaced immediately after cardioversion.
Patient Sequence No: 1, Text Type: D, B5
[83751025]
Oscor received addition information from the customer that this event was inadvertently reported twice, which resulted in oscor sending this report number 1035166-2017-00027 as a duplicate. The initial and final original report was submitted to the fda by oscor against report number 1035166-2016-00014. Based upon this additional information, oscor recognizes report number 1035166-2016-00014 as the official report and considers report number 1035166-2017-00027 closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035166-2017-00027 |
| MDR Report Key | 6437536 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-03-27 |
| Date of Report | 2017-06-07 |
| Date of Event | 2015-04-28 |
| 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 | 59312 |
| Catalog Number | 59312 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| 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 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-03-27 |