FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2921762
·
Received January 14, 2013
Report
- Report Number
- 1627487-2013-02091
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 26, 2012
- 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 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 REMAINED HOSPITALIZED AFTER HER IMPLANT SURGERY DUE TO A MODERATE ILEUS, CONGESTIVE HEART FAILURE AND PLEURAL EFFUSION. THE PT ALLEGEDLY HAS A HISTORY OF HEART PROBLEMS. HER HUSBAND STATED THE PT'S ABDOMEN WAS DISTENDED AND HARD AND SHE WAS CONSTIPATED DUE TO OPIOIDS. FOLLOW-UP ON (B)(6) 2012 INDICATED THE PT'S ABDOMINAL DISTENSION HAD RESOLVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19943 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3843027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| R | SCS IPG: MODEL 3688| IMPLANT DATE: |