FDA Adverse Event
Injury
Summary report: N
CAPSUREEPI
MDR report key: 2952740
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00221
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- February 8, 2018
- Manufacturer
- RICE CREEK MFG
- Product Code
- NVN
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: (B)(4) PACEMAKER, IMPLANTED: (B)(6) 2007. (B)(4).
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 THE PATIENT WAS EXPERIENCING LIGHT HEADEDNESS AND SHORTNESS OF BREATH. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLD, AND LOSS OF CAPTURE. THE RV LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56805 | CAPSUREEPI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | RICE CREEK MFG | 4965-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R | 4965 NON-DEFIB LEAD |