FDA Adverse Event
Injury
Summary report: N
KAPPA 700 DR
MDR report key: 2051576
·
Received April 12, 2011
Report
- Report Number
- 2647346-2011-00485
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD SLEEP PATTERNS DISTURBED. THE PATIENT CAME TO CLINIC TO HAVE THE DEVICE CHECKED. THE DEVICE HAD NOT BEEN CHECKED FOR SEVERAL YEARS PRIOR TO THIS CLINIC VISIT. THE DEVICE WAS NOT ABLE TO BE INTERROGATED AND THERE WAS NO TELEMETRY OR MAGNET RESPONSE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR701 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | 4068 X2 IMPLANTABLE PACING LEAD |