MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-01-23 for ENPATH 4046 manufactured by External Manufacturer.
[3124778]
.
Patient Sequence No: 1, Text Type: D, B5
[3307148]
Boston scientific received information that the patient experienced vibrations near his heart, at a location closer to his heart than to his device. Evidence suggests that the vibrations in the patient's chest may have started after a lead revision procedure. The patient presented to the emergency room (er) and a physician mentioned that one of the patient's leads may have come loose. An interrogation was to be performed. The leads remain actively implanted. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10487288]
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[10487408]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2013-01760 |
| MDR Report Key | 2927161 |
| Report Source | 04 |
| Date Received | 2013-01-23 |
| Date of Report | 2012-12-11 |
| Date of Event | 2012-12-05 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-01-23 |
| 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 | PATIENT |
| 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 | 2013-01-23 |
| Model Number | 4046 |
| ID Number | ENPATH |
| Device Expiration Date | 2013-12-01 |
| 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 | 4046 | 2013-01-23 |