FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-D
MDR report key: 2201342
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03757
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 3, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THERE WAS OVERSENSING AND NOISE ON THE DEVICE WITH POCKET MANIPULATION. THERE WAS ALSO PACING INHIBITION AT TIMES. 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 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | 5554 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |