MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-28 for DBS 3389 NA manufactured by Neuro.
[20926546]
Hcp reported a lead fell aprat during an attempt to connect the lead to a deep brain stimulator. Hcp noticed the poles disconnected from the insulation after a light tug. Upon closer examination of the proximal end, hcp noticed part of the insulation was cracked. The ipg and extension were not implanted. The lead was not removed. The lead had been implanted in 2003 but was never connected to any thing because the pt suffered a hemorrhage on the opposite side of the brain and had some cognitive decline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2004-00835 |
| MDR Report Key | 533152 |
| Report Source | 05 |
| Date Received | 2004-06-28 |
| Date of Report | 2004-06-17 |
| Date of Event | 2004-06-17 |
| Date Mfgr Received | 2004-06-17 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2004-07-09 |
| 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 | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | NEURO |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBS |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2004-06-28 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | B0160627K |
| ID Number | NA |
| Device Expiration Date | 2006-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 522420 |
| Manufacturer | NEURO |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | IMPLANTABLE LEAD FOR BRAIN STIMULATION |
| Baseline Model No | 3389 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-28 |