FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 3821018
·
Received May 7, 2014
Report
- Report Number
- 1627487-2014-05325
- Event Type
- Injury
- Date Received
- May 7, 2014
- Report Date
- April 16, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION 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
IT WAS REPORTED THE PT HAS EXPERIENCED MULTIPLE FALLS. IN TURN, THE PT HAS BEEN EXPERIENCING DIFFICULTY WITH THE CHARGER SUCCESSFULLY LOCATING AND COMMUNICATING WITH THE IPG. AS A RESULT, A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. REGARDLESS, THE PT MAY UNDERGO SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276816 | EON | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 173703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | SCS LEADS: MODEL 3186 (X2)| IMPLANT: |