FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 6006377
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-11856
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- July 18, 2016
- Report Date
- August 8, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
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 FOUR DAYS AFTER IMPLANT THAT THEY WERE FEELING SENSATIONS LIKE HICCUPS. THIS REPORT WAS CONFIRMED BY THE PATIENT'S CLINIC AS PART OF FOLLOW-UP TO DETERMINE THERE WAS DIAPHRAGMATIC STIMULATION ASSOCIATED WITH BOTH THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD. THE PACING OUTPUTS WERE REPROGRAMMED AT THAT TIME TO ADDRESS THE DIAPHRAGMATIC STIMULATION AND THE PATIENT'S CLINIC CONFIRMED IT WAS RESOLVED. THE PATIENT ALSO REFERENCED A POTENTIAL LOOSE LEAD BUT THE PATIENT'S CLINIC INDICATED THERE WAS NO CONCERN RELATED TO THE IMPLANTED LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657747 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | C6TR01 CRT-P, 5076-58 LEAD, 5076-52 LEAD |