FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 3152731
·
Received June 7, 2013
Report
- Report Number
- 3004209178-2013-09012
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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. CONCOMITANT PRODUCTS: 6947-65 IMPLANTABLE TACHY LEAD (B)(6) 2010; 4076-52 IMPLANTABLE PACING LEAD (B)(6) 2010; 4194-88 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY- THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS EARLY ELECTIVE REPLACEMENT INDICATOR AND THE PATIENT RECEIVED MANY SHOCKS. 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 |
|---|---|---|---|---|---|---|---|
| 253239 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| L| R |