MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-22 for POSSIS SUTURELESS MYOCARDIAL LEAD 4320 NA manufactured by Possis Medical Inc..
[21567]
During a routine replacement procedure of an implantable cardioverter defibrillator (icd) the pt's two myocardial rate sensing leads were capped and removed from service because the leads were discolored and blood was observed inside the leads. Implanted-6/12/92. Removed from service-1/2/96. Implanted-42 mo.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-1996-00014 |
| MDR Report Key | 30265 |
| Date Received | 1996-01-22 |
| Date of Report | 1996-01-17 |
| Date of Event | 1996-01-02 |
| Report Date | 1996-01-17 |
| Date Added to Maude | 1996-02-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSSIS SUTURELESS MYOCARDIAL LEAD |
| Generic Name | LEAD |
| Product Code | FIN |
| Date Received | 1996-01-22 |
| Model Number | 4320 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 51684 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30306 |
| Manufacturer | POSSIS MEDICAL INC. |
| Manufacturer Address | 2905 NORTHWEST BLVD MINNEAPOLIS MN 55441 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-01-22 |