FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2051977
·
Received April 12, 2011
Report
- Report Number
- 2649622-2011-05702
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- November 1, 2010
- Report Date
- August 1, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD LOW IMPEDANCES AND WAS NOT SENSING. THE LEAD WAS CAPPED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A RIGHT ATRIAL LEAD WARNING, A POLARITY SWITCH AND CRACKED INSULATION. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING THE ATRIAL PACING. THERE WAS REPROGRAMMING DONE FOR BOTH OF THE LEADS AND THEY BOTH 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MEDTRONIC PUERTO RICO, INC. | 4068 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | ADDR01 IMPLANTABLE PULSE GENERATOR |