FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3071708
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05202
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 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
- PA, 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: PRODUCT ID D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2011, PRODUCT ID 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005, 4538 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD THE RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND IT WAS ALSO EXTRACTED 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 |
|---|---|---|---|---|---|---|---|
| 172133 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Hospitalization| R |