FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3153307
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05937
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- March 18, 2013
- Report Date
- May 29, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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: 5054 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
FOLLOW UP WITH THE CLINIC DETERMINED THAT THE RA LEAD WAS FOUND TO HAVE DISLODGED. THE RA LEAD WAS REPOSITIONED AND REMAINS IN USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE ONE DAY POST IMPLANT CHECK, THE RIGHT ATRIAL (RA) LEAD APPEARED TO HAVE FAR FIELD R-WAVE OVERSENSING. THE RA LEAD THRESHOLDS HAD ALSO RISEN TO 3.25 VOLTS AT 0.4 MILLISECONDS. THE RA LEAD IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 254988 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R | ADDR01 IMPLANTABLE PULSE GENERATOR |