FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 4162426
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12782
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 MEDICAL PRODUCTS: 5072-45 LEAD, IMPLANTED (B)(6) 2001. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD UNEXPECTED LONGEVITY. THE ICD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO CAPTURE THROUGH THE ANALYZER. THE LV LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLDS AND A POSSIBLE FRACTURE. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640386 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R | D224TRK ICD, 694775 LEAD |