FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 3864633
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07560
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 24, 2014
- Report Date
- March 24, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE LEAD EXHIBITED HIGH THRESHOLD AND THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE PHYSICIAN DECIDED TO REMOVE AND REPLACED THE LEAD SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341262 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |