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 2020-03-31 for ATTAIN STARFIX LEAD 419578 manufactured by Mpri.
[186023730]
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated pacing capture threshold in the left ventricle was high. Analysis of the device memory indicated pacing capture threshold issue in the left ventricle. The device memory indicated pacing capture threshold in the left ventricle was unstable. Concomitant medical products: dtma2d1, icd, implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186023731]
It was reported that ten days post implant procedure, the cardiac resynchronization therapy defibrillator (crt-d) had premature battery depletion caused by high threshold measurements of left ventricular (lv) lead. It was noted that the lv lead seem to increase or variate significantly in thresholds. It was also noted that anodal stimulation was observed at lv threshold pacing with high voltage. Due to the covid-19 regulations the patient will not be called in for reprogramming until it is safe. The device and lv lead remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-06724 |
| MDR Report Key | 9908056 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2009-07-06 |
| Date Added to Maude | 2020-03-31 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTAIN STARFIX LEAD |
| Generic Name | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE |
| Product Code | OJX |
| Date Received | 2020-03-31 |
| Model Number | 419578 |
| Catalog Number | 419578 |
| Device Expiration Date | 2011-05-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |