MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-04-09 for UNKNOWN 4316 manufactured by Cpi - Del Caribe.
[2591473]
Boston scientific received information that during a routine check, this left ventricular (lv) lead showed frequent sensed events caused by noise, and high out of range pacing impedance measurements. It was unclear whether this lead had fractured. The patient's lv capture threshold was found to have increased to a value that was higher than the programmed output, but the patient was asymptomatic to loss of lv capture. The patient had intact 1:1 av nodal conduction. The clinician decided to program this lv lead off. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[2818062]
Boston scientific received information that during a routine check, this left ventricular (lv) lead showed frequent sensed events caused by noise, and high out of range pacing impedance measurements. It was unclear whether this lead had fractured. The patient's lv capture threshold was found to have increased to a value that was higher than the programmed output, but the patient was asymptomatic to loss of lv capture. The patient had intact 1:1 av nodal conduction. The clinician decided to program this lv lead off. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[9947338]
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 | 2124215-2012-04851 |
| MDR Report Key | 2523992 |
| Report Source | 07 |
| Date Received | 2012-04-09 |
| Date of Report | 2012-04-18 |
| Date of Event | 2011-09-09 |
| Date Mfgr Received | 2012-04-18 |
| Device Manufacturer Date | 2003-12-11 |
| Date Added to Maude | 2012-04-09 |
| 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 | CPI - DEL CARIBE |
| 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 | UNKNOWN |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2012-04-09 |
| Model Number | 4316 |
| ID Number | --- |
| Device Expiration Date | 2007-12-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CPI - DEL CARIBE |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-09 |