FDA Adverse Event
Injury
Summary report: N
QUATTRODE LEAD WIDE SPACED, 30 CM
MDR report key: 4513676
·
Received February 12, 2015
Report
- Report Number
- 1627487-2015-03044
- Event Type
- Injury
- Date Received
- February 12, 2015
- Report Date
- February 13, 2015
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UDI(DI): (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 3. REFERENCE MFR. REPORTS: 1627487-2015-03043 & 1627487-2015-03075.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2015-003043.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106532 | QUATTRODE LEAD WIDE SPACED, 30 CM | SCS LEAD | GZF | ST. JUDE MEDICAL - NEUROMODULATION | 3163 | 4328108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MODEL 3341, SCS EXTENSION| MODEL 3788, SCS IPG| MODEL 3244, SCS LEAD |