ENTERRA
Report
- Report Number
- 3004209178-2013-03673
- Event Type
- Injury
- Date Received
- March 13, 2013
- Report Date
- February 27, 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
- KY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).
.
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WENT TO THE COURT HOUSE ON (B)(6) 2013 WENT TO HER HEALTH CARE PROVIDER (HCP) WHO FOUND THAT THE DEVICE ¿MALFUNCTIONED AND TURNED ITSELF DOWN.¿ THE HCP REPORTEDLY RESET THE DEVICE TO THE ORIGINAL SETTINGS. THE PATIENT WAS THEN ¿REALLY SICK¿ ON (B)(6) 2013 AND WENT TO THE HCP. THE PATIENT FOUND OUT THAT THE DEVICE HAD ¿COMPLETELY DIED¿ AND THE REPORTER WANTED TO KNOW ¿WHAT THE SECURITY SYSTEM COULD HAVE DONE TO THE DEVICE.¿ FOUR DAYS LATER IT WAS REPORTED THAT THE DEVICE REACHED END OF SERVICE (EOS). THE PATIENT WAS TOLD THE DEVICE ¿WOULD LAST LONGER.¿ THE PATIENT BELIEVED HER HCP HAD HER STIMULATION ON AT ALL TIMES. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WAS HOSPITALIZED ¿AROUND THE FIRST WEEK OF (B)(6)¿ FOR FOUR DAYS DUE TO WHAT ¿THEY THOUGHT WAS A STOMACH VIRUS.¿ HOWEVER, IT WAS DISCOVERED THAT HER DEVICE HAD REACHED EOS. THE PATIENT STATED THAT THE DEVICE WAS TO BE REPLACED.
FOLLOW UP INFORMATION RECEIVED REPORTED THAT PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN ON (B)(6) 2013 AND THEIR CONCERNS WERE RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE CAUSE OF EVENT WAS FAILED BATTERY/BATTERY DEPLETION. THE DEVICE WAS REPLACED. MRI/X-RAY/CT SCAN ON (B)(6) 2013 SHOWED THAT THE PATIENT HAD A ¿NORMAL UPPER GASTROINTESTINAL.¿ THE PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FAIRLY SKINNY AND THE PATIENT COULD FEEL ¿LIKE A PULSATION IN HER RIGHT SIDE¿ WHEN SHE ATE. THE PATIENT COULD FEEL THE IMPLANTABLE NEUROSTIMULATOR (INS) PROTRUDE THROUGH HER SIDE. IT WAS NOTED THAT THE METAL DETECTOR POSSIBLY HAD ¿MESSED WITH THE FUNCTIONING¿ OF THE INS AND THE SETTINGS HAD BEEN ¿TURNED DOWN QUITE A BIT.¿
IT WAS REPORTED THAT A PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT HAD SYMPTOMS OF NAUSEA AND FELT "SICK AS A DOG." IT WAS REPORTED THAT THE SYMPTOMS OCCURRED AFTER THE PATIENT WAS EXPOSED TO A METAL DETECTOR ON (B)(6) 2013. IT WAS NOTED THAT THE DEVICE WAS TURNED ON AT THE TIME OF EXPOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105030 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00034 YR | Hospitalization| R |