FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3153218
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05873
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE AN ATRIAL LEAD WARNING APPEARED. THE ATRIAL LEAD IMPEDANCE AND THRESHOLD MEASUREMENTS WERE HIGH. OVERSENSING WAS ALSO NOTED. REPROGRAMMING OF THE LEAD WAS PERFORMED TO DECREASE OVERSENSING AND ENSURE CAPTURE UNTIL LEAD REPLACEMENT OCCURS. THE LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 256057 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SEDR01 IMPLANTABLE PULSE GENERATOR (IPG) |