FDA Adverse Event
Injury
Summary report: N
CRYSTALLINE PASSIVE FIXATION
MDR report key: 3992162
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-10019
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PRODUCT: ADDR01 IPG (B)(6) 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP VISIT THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH UNSTABLE THRESHOLDS, HIGH IMPEDANCE, AND A POSSIBLE FRACTURE. IT WAS ALSO REPORTED THERE WAS UNDERSENSING. REPROGRAMMING WAS DONE AND LATER, THE LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 470513 | CRYSTALLINE PASSIVE FIXATION | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | ICM09B52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR | Hospitalization| R | ICF09B45 LEAD |