FDA Adverse Event
Injury
Summary report: N
KAPPA 900 SR
MDR report key: 1875322
·
Received October 19, 2010
Report
- Report Number
- 2647346-2010-00660
- Event Type
- Injury
- Date Received
- October 19, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/014
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REPLACED AS IT HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS ANALYZED BY THE MANUFACTURER AND IT TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 900 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KSR901 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD |