D
Patient 1
THIS LEAD BECAME DISLODGED AND THE PHYSICIAN WAS UNABLE TO EXPLANT THIS LEAD SO IT WAS CAPPED AND REPLACED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
MAUDE MDR 2992865
- MDR report key
- 2992865
- Report number
- 1028232-2013-00472
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-12-07
- Date received
- 2013-03-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 6024 JEAN ROAD LAKE OSWEGO OR 97035 US
- Phone
- 877-877-8772
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COROX OTW 75-BP | LV LEAD | BIOTRONIK SE & CO. KG | NKE | 354805 | SEE MODEL NO. | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-03-01 | 0 | 1. H |
Event Narratives#
N
Patient 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.