FDA Adverse Event
Injury
Summary report: N
KAPPA 900 SR
MDR report key: 1990170
·
Received February 15, 2011
Report
- Report Number
- 2647346-2011-00151
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- June 1, 2010
- 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
- CA, 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) 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE HAD PREMATURE BATTERY DEPLETION AND NO OUTPUT. THE DEVICE WAS UNABLE TO BE INTERROGATED AND WAS 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 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KSR906 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACING LEAD |