MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for INST KIT 9734913 PROBE THORACIC ASSY manufactured by Medtronic Navigation, Inc.
[184080985]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184080986]
Medtronic received information regarding a navigation system that was used outside of procedure. It was reported that the site noticed two bent thoracic probes when sterilizing them. No patient was present. On 2020-feb-28 the manufacturer representative had contacted and also went to the account and put the new thoracic probes into the sets (2). She had spoken to multiple people from the site and it seems the site does not know where the 2 bent probes were place. Initial reporter provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-00959 |
| MDR Report Key | 9853203 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INST KIT 9734913 PROBE THORACIC ASSY |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-19 |
| Model Number | 9734913 |
| Catalog Number | 9734913 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |