FDA Adverse Event
Injury
Summary report: N
ISOLINE
MDR report key: 2992299
·
Received March 1, 2013
Report
- Report Number
- 1000165971-2013-00113
- Event Type
- Injury
- Date Received
- March 1, 2013
- Date of Event
- February 22, 2009
- Report Date
- February 5, 2013
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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
REPORTEDLY, RV OVERSENSING AND INAPPROPRIATE SHOCKS WERE REPORTED RELATIVE TO THE SUBJECT LEAD ON (B)(6) 2009. IN ORDER TO CORRECT THE INAPPROPRIATE SHOCKS THE VENTRICULAR SENSING WAS ADJUSTED (FROM 0.6 TO 0.8). ON (B)(6) 2009, THE PATIENT RETURNED FOR THE SAME SYMPTOMS. A RE-INTERVENTION WAS PERFORMED AND THE SUBJECT LEAD WAS REPLACED, AND LEFT IN-SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89120 | ISOLINE | MRM | SORIN CRM | ISOLINE 2CR6 | 2132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |