FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 3863275
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11005
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 25, 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
- 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. CONCOMITANT PRODUCT: 5076-52, LEAD, (B)(6) 2001; 6943-65, LEAD, (B)(6) 1998. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. IT WAS NOTED THAT THE PATIENT'S LEFT VENTRICLE HAS ELEVATED THRESHOLDS SINCE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
THE DEVICE WAS NOTED TO BE PART OF THE SYSTEM LONGEVITY STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341349 | 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 | 00072 YR | Hospitalization| R | 5071-53 LEAD, 5866-38M LEAD ADAPTER |