FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2952678
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01780
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 13, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. CONCOMITANT PRODUCT: 4543 COMPETITOR IMPLANTABLE PACING LEAD: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS REMOVED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56215 | CONCERTO CRT-D DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | C154DWK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD |