FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3071738
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05307
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 25, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. CONCOMITANT PRODUCTS: ADDR01 IMPLANTABLE PULSE GENERATOR, (B)(6) 2013; 37702 PAIN STIMULATOR IMPLANTABLE PULSE GENERATOR, (B)(6) 2008; 39565 PAIN STIMULATOR LEAD, (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD POOR SENSING. THE LEAD WAS REPOSITIONED AND 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 |
|---|---|---|---|---|---|---|---|
| 171937 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD |