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 2020-03-30 for QUARTET LEAD DOUBLE BEND, 86 CM 1457Q/86 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185487823]
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
[185487824]
It was reported that when the patient was undergoing the measurement check after implant, high thresholds were noted on the left ventricular (lv) lead as compared to the value recorded inside the operation room. Out of the four electrodes, electrode 3 and 4 of lv lead exhibited loss of capture, electrode 2 exhibited high threshold while electrode 1 exhibited acceptable value of threshold. The fluoroscopy image confirmed dislodgement of lv lead, but it was not totally dislodged. The physician decided to keep the lead implanted as one electrode was showing acceptable measurements. The patient did not experience any adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02302 |
| MDR Report Key | 9896912 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2020-03-30 |
| 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 | QUARTET LEAD DOUBLE BEND, 86 CM |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | OJX |
| Date Received | 2020-03-30 |
| Model Number | 1457Q/86 |
| Catalog Number | 1457Q/86 |
| Lot Number | A000088558 |
| 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 | 2020-03-30 |