FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 3991633
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14267
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 16, 2014
- 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
- MI, 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: 419688, LEAD, IMPLANTED: (B)(6) 2010; 5076-52, LEAD, IMPLANTED: (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION AND THE DEVICE WAS AT RRT (RECOMMENDED REPLACEMENT TIME). 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 |
|---|---|---|---|---|---|---|---|
| 469313 | 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 | 00050 YR | Hospitalization| R | 694765 LEAD |