MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-13 for ENPATH 4047 manufactured by External Manufacturer.
[2603338]
.
Patient Sequence No: 1, Text Type: D, B5
[9893413]
.
Patient Sequence No: 1, Text Type: N, H10
[19651128]
The lead was surgically abandoned and was not returned for testing. Therefore, boston scientific cannot confirm the reported clinical observations. No other adverse events have been reported. This product issue will be updated if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[19674059]
Boston scientific received information that during a routine follow up visit, a fracture of this left ventricular (lv) epicardial lead was revealed. A revision procedure was performed and the lead was removed from service and successfully replaced. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2012-00355 |
| MDR Report Key | 2415398 |
| Report Source | 07 |
| Date Received | 2012-01-13 |
| Date of Report | 2012-02-01 |
| Date of Event | 2011-12-28 |
| Date Mfgr Received | 2012-02-01 |
| Date Added to Maude | 2012-01-13 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHARON ZURN |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515824786 |
| Manufacturer G1 | EXTERNAL MANUFACTURER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENPATH |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2012-01-13 |
| Model Number | 4047 |
| ID Number | ENPATH |
| Device Expiration Date | 2009-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTERNAL MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4047 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2012-01-13 |