FDA Adverse Event
Malfunction
Summary report: N
TARGET TIP
MDR report key: 3863138
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06639
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 16, 2014
- Report Date
- January 13, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K822781
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. PRODUCTS: 47901 INTERMEDICS LEAD, IMPLANT DATE UNK. (B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD AGAIN TRIGGERED A LEAD WARNING FOR LOW IMPEDANCE. THE LEAD REMAINS IN USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIPOLAR RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD WARNING FOR LOW IMPEDANCE. THE RV LEAD REMAINS IN USE AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339534 | TARGET TIP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 401158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR |