MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-11 for UNKNOWN 4312 manufactured by Historical Cpi St. Paul.
[15513066]
Boston scientific received information that during a device check, the pacer dependent patient with this device system reported feeling pre-syncopal and light headed while sitting upright. Device testing was not performed in this position. The patient endured chronic atrial fibrillation (af). Additionally, fine noise was observed. While laying down, the patient felt no symptoms and impedance measurements in this position were within acceptable limits. Pacing inhibition slightly greater than two seconds was observed on the electrogram (egm). A revision procedure was performed and an right ventricular (rv) lead was placed on the right side of the body and the right atrial (ra) port was plugged. The chronic abdominal leads were surgically abandoned and the chronic device was moved to the right side. No adverse patient effects were reported during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[15600246]
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
| Report Number | 2124215-2012-16155 |
| MDR Report Key | 2911308 |
| Report Source | 05 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-11-28 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2013-01-11 |
| 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 | UNKNOWN |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2013-01-11 |
| Model Number | 4312 |
| ID Number | --- |
| Device Expiration Date | 1995-08-02 |
| 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 | 41 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-01-11 |