MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-02-22 for SYNCHROMED EL 8627 NA manufactured by Rice Creek Manufacturing.
[607939]
Medtronic received returned product for analysis and disposal after an implant duration of 75 months. The infusion pump was programmed to infuse bupivicaine 40mg/ml at 1. 842mg/day.
Patient Sequence No: 1, Text Type: D, B5
[7961300]
Final device analysis reveals: motor shaft gear wear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000030-2007-00644 |
| MDR Report Key | 839785 |
| Report Source | 01,05 |
| Date Received | 2007-02-22 |
| Date of Report | 2007-01-31 |
| Date of Event | 2006-01-23 |
| Date Mfgr Received | 2007-01-31 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2007-04-23 |
| 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 | 3 |
| Manufacturer Contact | RENEE MACK, R.N. B.S.N. |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050818 |
| Manufacturer G1 | RICO CREEK MANUFACTURING |
| Manufacturer Street | 7000 CENTRAL AVENUE NORTH EAST |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHROMED EL |
| Generic Name | LLK |
| Product Code | LLK |
| Date Received | 2007-02-22 |
| Returned To Mfg | 2006-11-28 |
| Model Number | 8627 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2000-07-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 827067 |
| Manufacturer | RICE CREEK MANUFACTURING |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-22 |