ENTERRA
Report
- Report Number
- 3004209178-2013-02514
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- January 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER SHOWED SHE WAS SEEN ON (B)(6) 2013. THE PATIENT REPORTED "SHOCKING SENSATION, LEGS TEMPORARILY WENT NUMB" WHEN WALKING THROUGH SECURITY GATE AT A DEPARTMENT STORE. THE PATIENT ALSO REPORTED "SOME NAUSEA BUT NO VOMITING," BUT "OTHERWISE FEELS WELL." DEVICE INTERROGATION SHOWED THERAPY IMPEDANCES WERE WITHIN NORMAL LIMITS. NO FURTHER ISSUES WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "TERRIBLE SHOCK" THAT CAUSED NUMBNESS IN HER LEGS AND TO DROP HER SHOPPING BAGS WHILE AT A STORE DURING (B)(6) SHOPPING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
IN ADDITION TO THE PREVIOUSLY REPORTED INFORMATION, IT WAS ALSO REPORTED THE PATIENT HAD DIARRHEA AT HER LAST OFFICE VISIT THREE MONTHS AGO, BUT IT HAD RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58208 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR |