FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S LEAD
MDR report key: 6118015
·
Received November 21, 2016
Report
- Report Number
- 2938836-2016-14578
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Date of Event
- October 28, 2016
- Report Date
- October 31, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE, HIGH CAPTURE AND LOW SENSING WAS OBSERVED. PHYSICIAN TRIED DIFFERENT POSITIONS BUT COULD NOT FIND THE APPROPRIATE MEASUREMENTS. THE LEAD WAS EXPLANTED AND WAS REPLACED. PATIENT¿S CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767199 | ISOFLEX S LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1642T/52 | A000012207 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |