FDA Adverse Event
Injury
Summary report: N
ISOFLEX OPTIM LEAD
MDR report key: 4862512
·
Received June 23, 2015
Report
- Report Number
- 2017865-2015-08034
- Event Type
- Injury
- Date Received
- June 23, 2015
- Date of Event
- April 28, 2015
- Report Date
- April 28, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960030
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE PHYSICIAN'S OFFICE. THE ATRIAL LEAD HAD BECOME DISLODGED AND EXHIBITED A LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL AND WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406397 | ISOFLEX OPTIM LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1944/52 | 4827708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |