FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 2201399
·
Received August 11, 2011
Report
- Report Number
- 2647346-2011-01007
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/014
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT QUESTIONED WHY THE DEVICE DID NOT LAST AS LONG AS ESTIMATED AT THE APPOINTMENT FIVE MONTHS PRIOR TO THE ELECTIVE REPLACEMENT INDICATOR (ERI) BEING TRIGGERED. THE PATIENT REPORTED FEELING UNWELL BEING TIRED ALL OF THE TIME WHEN THE DEVICE REACHED ERI. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 900 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR901 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | 4568 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD |