MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-09 for PATCH 0040 manufactured by Historical Cpi St. Paul.
[3040364]
Boston scientific received information that this right ventricular (rv) defibrillation patch lead exhibited shock impedances greater than 125 ohms. During the routine device change out, the lead was deactivated and replaced. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10209215]
The right ventricular (rv) lead was not returned to boston scientific; therefore, the clinical observations could not be confirmed. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated and an amended report submitted should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-11403 |
| MDR Report Key | 2778770 |
| Report Source | 05 |
| Date Received | 2012-10-09 |
| Date of Report | 2012-08-16 |
| Date of Event | 2012-08-15 |
| Date Mfgr Received | 2012-08-16 |
| Date Added to Maude | 2012-10-09 |
| 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 | 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 CPI ST. PAUL |
| Manufacturer Street | GUIDANT CORPORATION |
| Manufacturer City | SAINT PAUL MN |
| 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 | 2012-10-09 |
| Model Number | 0040 |
| ID Number | A 67 |
| Device Expiration Date | 1993-02-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HISTORICAL CPI ST. PAUL |
| Manufacturer Address | GUIDANT CORPORATION SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1600 | 1. Hospitalization; 2. Required No Informationntervention | 2012-10-09 |