FDA Adverse Event
Injury
Summary report: N
UNIFY ASSURA CRT-D RF HV
MDR report key: 4863849
·
Received June 23, 2015
Report
- Report Number
- 2938836-2015-27373
- Event Type
- Injury
- Date Received
- June 23, 2015
- Date of Event
- May 21, 2015
- Report Date
- May 21, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NIK
- PMA / PMN Number
- P970013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO POCKET EROSION. ONE WEEK POST IMPLANT HEMATOMA WAS OBSERVED AND AS A RESULT THE PHYSICIAN REOPENED AND RESEALED THE POCKET. IT WAS LATER REPORTED THAT THE PATIENT HAD BLEEDING AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT AT GENERATOR CHANGE CAUTERY WAS APPLIED TO REMOVE THE NON-DISSOLVABLE ANTIBIOTIC POUCH AND MAY HAVE LED TO THE TISSUE DYING. THE PATIENT WAS DOWNGRADE TO A DUAL CHAMBER. THE NEW SYSTEM WAS IMPLANTED SUB-PECTORALLY. THE PATIENT WAS STILL IN HOSPITAL BUT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407363 | UNIFY ASSURA CRT-D RF HV | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD3357-40C | A000000840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |