MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-09-11 for INDURA 8703W NA manufactured by Medtronic Inc..
[98517]
Initial information received from company representative indicated that patient presented to hospital emergency room 2 days post implant with red inflammed tissue along the exact site of the intrathecal catheter. The patient was placed on antibiotics and the reactive site was cultured with negative results. A skin test was not performed to determine the exact cause of the patient's reaction. The device was explanted. Follow-up information was received at a later date which revealed that the physician collected scrapings from both the pump and catheter for culture, which were both negative. The patient has multiple health problems, including multiple sclerosis, with the results that the physician feels her immune system is compromised and may have been overly sensitive to trigger this type of reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-1998-00205 |
| MDR Report Key | 187273 |
| Report Source | 07 |
| Date Received | 1998-09-11 |
| Date of Report | 1998-07-07 |
| Date of Event | 1998-06-25 |
| Date Mfgr Received | 1998-07-01 |
| Date Added to Maude | 1998-09-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDURA |
| Generic Name | INTRATHECAL CATHETER |
| Product Code | MAJ |
| Date Received | 1998-09-11 |
| Model Number | 8703W |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 182038 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | INDURA |
| Baseline Generic Name | INTRATHECAL CATHETER |
| Baseline Model No | 8703W |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-11 |