FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 3151721
·
Received June 7, 2013
Report
- Report Number
- 3004209178-2013-08819
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 4, 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
- MA, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 92% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. A 4196 IMPLANTABLE PACING LEAD, (B)(6) 2009. A 4473 COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED POSSIBLE EARLY BATTERY DEPLETION. 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 |
|---|---|---|---|---|---|---|---|
| 253154 | CONCERTO CRT-D DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | C154DWK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |