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 2018-10-23 for ADAPTOR KIT 5866 manufactured by Medtronic, Inc..
[124752536]
Concomitant medical products: 5071-53 lead, implanted: (b)(6) 2018. 5071-53 lead, implanted: (b)(6) 2007. Lnq11 icm, implanted: (b)(6) 2016. 310c27 tissue valve, implanted: (b)(6) 2016. 5076-45 lead, implanted: (b)(6) 2013. 4058m52 lead, implanted: (b)(6) 1992. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[124752537]
It was reported that the patient presented to the emergency room (er) with dizziness, syncope, and bradycardia. The patient is pacemaker dependent. The epicardial right ventricular (rv) lead was oversensing and causing pauses in the patient? S heart rate. The lead had high thresholds. Troubleshooting revealed that the epicardial rv anode lead was the lead that was causing the issue. The rv anode lead was suspect of a fracture. The pacing configuration was programmed from a bipolar mode to unipolar mode, effectively programming off the rv anode lead and the issue was resolved. The rv cathode lead remains in use. The rv anode lead remains in the patient out of service. It was further reported that the patient had ventricular fibrillation (vf) that was related to profound bradycardia and short-long intervals of escape rhythm. The patient had an episode of vf that required external rescue. The patient was presented to the er with complete loss of pacing. There was no pacemaker function visible on surface electrocardiograph (ekg) despite magnet application. The loss of pacing resolved spontaneously after a temporary pacemaker was placed. The pacemaker was unable to be interrogated in the er due to interference with the cardiac monitor. The pacemaker was later interrogated in the electrophysiology (ep) lab and there were no ventricular high rate episodes, only an observation of chronic low impedance warning in the rv epicardial leads. The pacemaker and the cardiac monitor were removed to avoid interrogation interactions. A new cardiac resynchronization therapy pacemaker (crt-p) was implanted. The rv cathode was plugged into the left ventricular (lv) port of the crt-p and remains in use. The rv anode was capped. A new intravenous rv lead was implanted. It was further reported that the physician suspects there is a connection issue with the y-adaptor connector or a conductor failure within the adaptor. The adaptor was removed from use. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[126405651]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129510535]
Product event summary: the full adaptor was returned, analyzed, and no anomalies were found. Visual analysis of the adaptor indicated apparent explant damage. The analyst noted the setscrews are fully operational with no anomaly. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2018-01931 |
| MDR Report Key | 7997131 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-23 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-10-23 |
| 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 | ADAPTOR KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2018-10-23 |
| Returned To Mfg | 2018-08-28 |
| Model Number | 5866 |
| Catalog Number | 5866 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-10-23 |