FDA Adverse Event
Injury
Summary report: N
ISOLINE
MDR report key: 2992305
·
Received March 1, 2013
Report
- Report Number
- 1000165971-2013-00119
- Event Type
- Injury
- Date Received
- March 1, 2013
- Date of Event
- February 17, 2013
- Report Date
- February 21, 2013
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN EPISODE OF VENTRICULAR FIBRILLATION AT 06:04 AM ON (B)(6) 2013, THE IMPLANTED ICD SYSTEM FAILED TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY. REPORTEDLY, THE SYSTEM DETECTED THE VF, BUT SHOCK THERAPY WAS NOT DELIVERED DUE TO LOW RV LEAD IMPEDANCE (<200 OHM) AND LOW SHOCK IMPEDANCE. THE PATIENT RECEIVED CPR (CARDIO-PULMONARY RESUSCITATION), AND WAS THEN DEFIBRILLATED AT 06:31 AM. THE ICD SYSTEM IS PLANNED TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89123 | ISOLINE | MRM | SORIN CRM | ISOLINE 2CR6 | 2216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |