FDA Adverse Event
Injury
Summary report: N
TARGET TIP
MDR report key: 3062155
·
Received April 16, 2013
Report
- Report Number
- 2649622-2013-05114
- Event Type
- Injury
- Date Received
- April 16, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K822781
- 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. PRODUCT ID ADDR06 (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE HAS BEEN DECREASING AND IS NOW LOW. THE THRESHOLD WAS ALSO HIGH. THE PATIENT HAD ALSO BEEN EXPERIENCING MUSCLE STIMULATION FOR SEVERAL MONTHS. THE LEAD HAD A POSSIBLE INSULATION BREAK. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162246 | TARGET TIP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 401158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Hospitalization| R | 4574 IMPLANTABLE PACING LEAD |