MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-11 for SYNCHROMED PROGRAMABLE PUMP 8615L manufactured by Medtronic.
[18839]
Malfunctioning co pump and tubing were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26941 |
| MDR Report Key | 26941 |
| Date Received | 1995-08-11 |
| Date of Report | 1995-03-08 |
| Date of Event | 1995-02-23 |
| Date Facility Aware | 1995-02-23 |
| Report Date | 1995-03-08 |
| Date Reported to Mfgr | 1995-03-08 |
| Date Added to Maude | 1995-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | SYNCHROMED PROGRAMABLE PUMP |
| Generic Name | PUMP |
| Product Code | LKX |
| Date Received | 1995-08-11 |
| Returned To Mfg | 1995-03-08 |
| Model Number | 8615L |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 27724 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | P.O. BOX 1399T-140 MINNEAPOLIS MN 55440 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-08-11 |