MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-30 for PATCH 0040 manufactured by Historical Cpi St. Paul.
[2833351]
Boston scientific received information that shortly after the implant of a new pulse generator, high shock impedances greater than 125 ohms were noted in the triad configuration. Rv coil to can configurations were noted to be within range. Defibrillation testing was performed at a follow up to test the integrity of the system, which was successfully completed at 31 joules. Additionally, the device memory was saved to a disk and sent to boston scientific to analyze the root cause of the issue. No other testing or remedial action was needed and the physician will continue to monitor the patient. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10113617]
The disk analysis on this device shows that the shock impedance in any configuration with the ra coil involved is out of range. This probably reflects an open lead condition on the ra shocker such as an electrode fracture or an issue with the 6931 adapter. Records show the patient has two implanted adaptors, however it is not specified which is connected to the ra coil. There was no indication of pg malfunction from the disk diagnostics. The device remains in service. 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 | 2124215-2012-10365 |
| MDR Report Key | 2674565 |
| Report Source | 07 |
| Date Received | 2012-07-30 |
| Date of Report | 2012-06-26 |
| Date of Event | 2012-06-26 |
| Date Mfgr Received | 2012-06-26 |
| Date Added to Maude | 2012-07-30 |
| 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 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 | 2012-07-30 |
| Model Number | 0040 |
| ID Number | A 67 |
| Device Expiration Date | 1992-05-21 |
| 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 | 6931 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2012-07-30 |