FDA Adverse Event
Malfunction
Summary report: N
MYOCARDIAL LEAD
MDR report key: 3861584
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07222
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- May 8, 2012
- Report Date
- April 29, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- K031274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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: 6947M62 LEAD, IMPLANTED: (B)(6) 2012; 457445 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SUDDEN RISE IN THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LEAD WAS NOTED TO BE PART OF THE PRODUCT SURVEILLANCE REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342842 | MYOCARDIAL LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5071-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | D314TRM CRT-D |