FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3153437
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06016
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 15, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH 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: 5524M IMPLANTABLE PACING LEAD (B)(6) 1994; 284-05 COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 1994. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS BOTH SHOWED NOISE ON THE ELECTROGRAM ALONG WITH MIRROR LIKE IMAGES. THERE WAS ALSO NOTED A SLIGHT INCREASE IN THRESHOLDS. BOTH LEADS REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 256680 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5024M-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |