FDA Adverse Event
Malfunction
Summary report: N
MYOCARDIAL LEAD
MDR report key: 6006637
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-12034
- Event Type
- Malfunction
- Date Received
- October 6, 2016
- Date of Event
- July 2, 2016
- Report Date
- July 2, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P120017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2008; 694265, LEAD, IMPLANTED: (B)(6) 1999.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR LOW IMPEDANCE ON THE LEFT VENTRICULAR (LV). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656058 | MYOCARDIAL LEAD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5071-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | DTBA1D1 ICD |