FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3160294
·
Received June 10, 2013
Report
- Report Number
- 2649622-2013-07963
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- April 25, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 5568 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD DISLODGED DUE TO THE PATIENT HAVING TWIDDLERS SYNDROME. AN ATTEMPT WAS MADE TO REPOSITION THE RA LEAD BUT THE HELIX WOULD NOT EXTEND AGAIN SO THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW RA LEAD. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260781 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |