MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-06 for UNKNOWN 4316 manufactured by Cpi - Del Caribe.
[17136279]
Boston scientific received information that this product is scheduled for a system revision in the future due to infection. The device will be explanted and a new device inserted deeper into the pocket. There were no additional adverse effects reported. The device will be returned for analysis. Additional information was received that during a device replacement procedure, the implanted system was removed and replaced with laser extraction and implanted through the right subclavian vein. All leads and the device were removed except the distal part of the 4471 rv-p/s lead was noted to be ripped in two pieces during the extraction. The system was successfully tested with and induced t-wave shock (1,1j) during the implant procedure and caused ventricular fibrilation which was terminated by the first shock with 31j. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[17402544]
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 | 2124215-2012-07335 |
| MDR Report Key | 2642457 |
| Report Source | 05 |
| Date Received | 2012-07-06 |
| Date of Report | 2012-04-26 |
| Date of Event | 2012-04-10 |
| Date Mfgr Received | 2012-04-26 |
| Device Manufacturer Date | 2002-01-23 |
| Date Added to Maude | 2012-07-06 |
| 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 | 2012-07-06 |
| Model Number | 4316 |
| ID Number | --- |
| Device Expiration Date | 2006-01-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 158 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2012-07-06 |