FDA Adverse Event
Injury
Summary report: N
GENESIS IMPLANTABLE PULSE GENERATOR
MDR report key: 2040989
·
Received March 25, 2011
Report
- Report Number
- 1627487-2011-02305
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 25, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 MANUFACTURER REPORT: 1627487-2011-02304. THE PT ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD AND AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE IPG AND LEAD WERE EXPLANTED AS THEY HAD BECOME DISCONNECTED WITHIN THE IMPLANT POCKET. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3608 | 2898572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |