FDA Adverse Event
Injury
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 12783365
·
Received November 9, 2021
Report
- Report Number
- 2017865-2021-36183
- Event Type
- Injury
- Date Received
- November 9, 2021
- Date of Event
- October 18, 2021
- Report Date
- November 24, 2021
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- DTB
- PMA / PMN Number
- K900645
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATED BY MANUFACTURER? "NO" SELECTED BY MISTAKE, THE PRODUCT IS STILL IMPLANTED.
Additional Manufacturer Narrative · 0
DI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE SEPTEMBER 23, 2014 CORRECTION: PREVIOUSLY REPORTED DEVICE PRODUCT CODE (D2) SHOULD HAVE BEEN "DTB" RATHER THAN "NVN".
Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Description of Event or Problem · 0
NEW INFORMATION INDICATES THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679398 | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 033-444 | |||
| 1679399 | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 033-444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |