FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2953714
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01328
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE HELIX DEPLOYED NORMALLY. DURING THE LEAD PLACEMENT, THERE WERE SEVERAL DISLODGEMENTS RESULTING IN SEVERAL REPOSITIONINGS. THEN THE HELIX WOULD NOT RETRACT AFTER TWENTY-FIVE TO THIRTY TURNS WHILE IN THE BODY. THE PHYSICIAN REMOVED THE LEAD AND ONCE OUTSIDE THE BODY THE HELIX RETRACTED. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56392 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00092 YR |