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 2020-03-26 for QUICKFLEX LV LEAD 1156T/75 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185079541]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185079542]
It was reported that the patient presented in clinic for a follow up. During device interrogation, the ring conductor of left ventricular lead appeared to be failing which resulted in high pacing impedance and high capture. Programming changes were made. The patient was very sensitive to alterations of the pacing parameters and felt discomfort. Further intervention was discussed. The patient will continue to be monitored.
Patient Sequence No: 1, Text Type: D, B5
[187340130]
Related manufacturer reference number: 2938836-2020-02431. New information received notes that since the patient was very sensitive, the right ventricular lead pacing also caused patient discomfort. The lead was turned off. The patient currently is paced on lv only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-01829 |
| MDR Report Key | 9884237 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2008-06-12 |
| Date Added to Maude | 2020-03-26 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKFLEX LV LEAD |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | OJX |
| Date Received | 2020-03-26 |
| Model Number | 1156T/75 |
| Lot Number | 0002664442 |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |