FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3862410
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06942
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 9, 2014
- Report Date
- April 18, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
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: 5076-52, LEAD, IMPLANTED: (B)(6) 2014; 6935M62, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE PATIENT HAD CARDIOVERSION FOR ATRIAL FIBRILLATION AND THE DEVICE WAS REPROGRAMMED TO TURN THE LEAD BACK ON.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS ELECTRICALLY ABANDONED AND REMAINS IN THE PATIENT. THE PATIENT WAS ENROLLED IN (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337918 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention | DTBB1D4 CRT-D |