FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY STRAIGHT
MDR report key: 6160517
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-14163
- Event Type
- Injury
- Date Received
- December 9, 2016
- Date of Event
- April 21, 2016
- Report Date
- October 6, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- UDI-DI
- 00613994719058
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED SOMETIME AFTER IMPLANT. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 810167 | ATTAIN ABILITY STRAIGHT | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 439688 | 00613994719058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R | 5076-52 LEAD, 6935M62 LEAD, DTBA1D4 ICD |