FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 4160232
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11979
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 MEDICAL PRODUCTS: 6945-65 LEAD, IMPLANTED: (B)(6) 2000. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE ARE NUMEROUS RECORDINGS OF NONPHYSIOLOGICAL NOISE ON BOTH THE ATRIAL AND VENTRICULAR EGMS. THE SHORT INTERVAL COUNTS (SIC) HAVE BEEN HISTORICALLY ELEVATED. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638989 | CAPSUREFIX | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6940-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | D314DRG ICD |