TENDRIL SDX LEAD · Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Abbott Medical (CRM-Sylmar) · Signal Artifact/Noise
- Report to FDA
- N
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Sylmar
- Manufacturer contact address 1
- 15900 Valley View Court
- Event type
- Injury
- Report number
- 2017865-2026-20334
- Product problem flag
- Y
- Date received
- 20260930
- PMA pmn number
- P960013
- Date of event
- 20260910
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 91342
- Reporter occupation code
- PHYSICIAN
- Noe summarized
- 1
- Manufacturer contact l name
- Singh
- Manufacturer g1 postal code
- 91342
- Manufacturer g1 state
- CA
- Reporter country code
- US
- Date added
- 20260930
- Manufacturer contact f name
- Navpreet
- Device date of manufacturer
- 20020919
- Previous use code
- I
- Reporter state code
- WA
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- Y
- Summary report flag
- N
- Date report
- 20260929
- Initial report to FDA
- No
- Manufacturer g1 country
- US
- Manufacturer contact city
- Sylmar
- MDR report key
- 50941438
- Date manufacturer received
- 20260910
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 91342
- Manufacturer g1 name
- Abbott Medical (CRM-Sylmar)
- Adverse event flag
- Y
- Single use flag
- Y
- Manufacturer g1 address 1
- 15900 Valley View Court
- Manufacturer contact postal code
- 91342
- Type of report
- Initial submission
- Source type
- Health Professional, User facility, Company representation
- Device
- Device sequence number
- 319550
- Implant date year
- 2003
- Serviced by 3rd party flag
- N
- Date received
- 20260930
- Brand name
- TENDRIL SDX LEAD
- Generic name
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- Manufacturer d name
- Abbott Medical (CRM-Sylmar)
- Manufacturer d address 1
- 15900 Valley View Court
- Manufacturer d city
- Sylmar
- Manufacturer d state
- CA
- Manufacturer d zip code
- 91342
- Manufacturer d country
- US
- Manufacturer d postal code
- 91342
- Device operator
- HEALTH PROFESSIONAL
- Expiration date of device
- 20040930
- Model number
- 1488TC/46
- Lot number
- 0002679707
- Device availability
- No
- Device report product code
- NVN
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- Medical specialty description
- Unknown
- Device class
- 3
- Product problems
- Signal Artifact/Noise
- Patient
- Patient sequence number
- 1
- Date received
- 20260930
- Patient age
- 86 YR
- Patient sex
- Male
- Sequence number outcome
- Required Intervention
- Patient problems
- No Clinical Signs, Symptoms or Conditions