MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-09 for PATCH 0041 manufactured by Historical Cpi St. Paul.
[3359795]
Boston scientific received information that during an elective change out procedure, this lead exhibited high out of range shocking impedance measurements when attached to the competitive device. Since the lead's shock impedance measurements with the previous boston scientific device had been within normal range, the physician performed defibrillation threshold (dft) testing. Using the bust method the patient was induced into fibrillation, but was unable to be converted and the shock impedance still measured greater than 200 ohms. Subsequently the right ventricular (rv) patch was replaced with a lead. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10644426]
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 | 2124215-2013-03416 |
| MDR Report Key | 3044140 |
| Report Source | 07 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-02-06 |
| Date of Event | 2013-01-18 |
| Date Mfgr Received | 2013-02-06 |
| Date Added to Maude | 2013-04-09 |
| 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 | 2013-04-09 |
| Model Number | 0041 |
| ID Number | L 67 |
| Device Expiration Date | 1995-02-16 |
| 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 | 1550 | 2013-04-09 |