FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 7893463
·
Received September 20, 2018
Report
- Report Number
- 2649622-2018-15390
- Event Type
- Malfunction
- Date Received
- September 20, 2018
- Date of Event
- September 10, 2018
- Report Date
- September 20, 2018
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169550759
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 BY THE PATIENT THAT THEY WERE TOLD ''THE LEAD IS DISCONNECTED''. THE PATIENT ALSO REPORTED THAT ''WHEN I LIE DOWN FLAT, I GET A LUMP BETWEEN THE PACEMAKER AND THE CLAVICLE. WHEN I'M SITTING STRAIGHT, I DON'T HAVE THAT LUMP.'', THAT ''THE TOP OF MY RIGHT FOOT IS NUMB AND IT GOES AWAY AT NIGHT.'' AND THAT ''ON MY ARM I'M GETTING THIS SHARP PAIN.''. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736797 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 | 00643169550759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | A2DR01 IPG, 5076-52 LEAD |