MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-06 for PATCH 0041 manufactured by Historical Puerto Rico.
[20734868]
Boston scientific received information that during a normal device changeout, this epicardial lead patch was noted to be fractured. Fluoroscopy confirmed that there was a break in the patch conductor coils. The lead was surgically abandoned and replaced with no adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[20904891]
The lead was surgically abandoned. No further information is available. This report will be updated if more information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-01718 |
| MDR Report Key | 2520267 |
| Report Source | 07 |
| Date Received | 2012-04-06 |
| Date of Report | 2012-01-27 |
| Date of Event | 2012-01-27 |
| Date Mfgr Received | 2012-01-27 |
| Date Added to Maude | 2012-04-06 |
| 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 | HISTORICAL PUERTO RICO |
| Manufacturer Street | GUIDANT PUERTO RICO B. V. |
| Manufacturer City | DORADO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATCH |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2012-04-06 |
| Model Number | 0041 |
| ID Number | L 67 |
| Device Expiration Date | 1997-06-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HISTORICAL PUERTO RICO |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-06 |