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 2020-03-30 for ACUITY X4 STRAIGHT 4671 manufactured by Boston Scientific Corporation.
[185774755]
Upon receipt at our post market quality assurance laboratory, an evaluation of this lead was performed. The guidewire insertion difficulty allegation could not be confirmed by lab analysis due to induced damage. Analysis showed that the lead body was extremely twisted or coiled, likely from being pulled. At the lead tip, coils were stretched-out and insulation was ripped apart.
Patient Sequence No: 1, Text Type: N, H10
[185774756]
It was reported that this left ventricular (lv) lead was not implanted successfully as the lead would not go over guidewire and got stuck. The lv lead was never in service. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-03298 |
| MDR Report Key | 9901031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-09-13 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | ROAD 698, LOT NO. 12 |
| Manufacturer City | DORADO PR 00646-260 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00646-2602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY X4 STRAIGHT |
| Generic Name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code | LWP |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 4671 |
| Catalog Number | 4671 |
| Lot Number | 825540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |