MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for 518932 manufactured by Medtronic, Inc..
[180610603]
From staff: patient has a temp wire. Pacer was hung on iv pole. Was turning patient and pacer holder ripped away. Pacer fell on patients' head. Patient has a small hematoma as well. Patient stated that when was turned onto right side to be repositioned arm got caught on the cable from the pacer wire to the generator and it pulled the bag off the pole resulting in being hit on left side of forehead. Patient said it initially was sore but now has no feeling of pain in that area. A small hematoma was initially reported but could only see a very small (5 mm round) flat pink spot. Pacer generator was hung in approved bag at the time but should not have been up so high on iv pole. Pacer is now hung in approved bag on built in iv pole at head of bed with adequate cable securement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744387 |
| MDR Report Key | 9744387 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-17 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NA |
| Generic Name | PACEMAKER LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2020-02-24 |
| Catalog Number | 518932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |