FDA Adverse Event
Death
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3181539
·
Received June 21, 2013
Report
- Report Number
- 2649622-2013-08116
- Event Type
- Death
- Date Received
- June 21, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. PRODUCT ID D314TRG, IMPLANTED: (B)(6) 2013; PRODUCT ID 6944-65, IMPLANTED: (B)(6) 2001; PRODUCT ID 5076-52, IMPLANTED:(B)(4) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION REQUIRING THE IMPLANTABLE CARDIAC DEFIBRILLATION (ICD) SYSTEM TO BE REMOVED. DURING THE REMOVAL OF THE ICD SYSTEM THE PHYSICIAN REPORTED THE PATIENT DIED AND THAT THE LASER LEAD EXTRACTION MAY HAVE CONTRIBUTED TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281886 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Death |