FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 2973652
·
Received February 19, 2013
Report
- Report Number
- 1627487-2013-05232
- Event Type
- Injury
- Date Received
- February 19, 2013
- Date of Event
- January 24, 2013
- Report Date
- January 24, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR REPORT#: 1627487-2013-05231. ON (B)(6) 2013, THE PT UNDERWENT A TRIAL PROCEDURE. DURING THE PROCEDURE, THE DOCTOR WAS UNABLE TO PLACE TWO LEADS DUE THE PT'S ANATOMY AND SCAR TISSUE. THE PROCEDURE LASTED TWO HOURS AND WAS ABORTED. NO PRODUCT WILL BE RETURNED TO SJM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72694 | UNKNOWN | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |