FDA Adverse Event
Injury
Summary report: N
KAPPA 700 D
MDR report key: 1792508
·
Received August 11, 2010
Report
- Report Number
- 6000023-2010-00015
- Event Type
- Injury
- Date Received
- August 11, 2010
- Manufacturer
- MEDTRONIC, B.V.
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) BATTERY DEPLETION-NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION. DURING EXPLANTATION OF THE DEVICE, THE HEADER APPEARED TO HAVE EROSION WHERE THE LEADS ARE INSERTED INTO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 700 D | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC, B.V. | KD706 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |