FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3152465
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06789
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 26, 2013
- Report Date
- April 26, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THIRTY MINUTES POST-IMPLANT, THERE WAS A MICRO-DISLODGEMENT OF THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252825 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4092-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R | SEDR01 IMPLANTABLE PULSE GENERATOR |