ENTERRA
Report
- Report Number
- 3004209178-2013-07905
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
.
CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THE PATIENT STILL HAD HER PRIOR IMPLANTED PULSE GENERATORY (IPG) AND LEADS IMPLANTED AND INACTIVE ON THE RIGHT SIDE OF HER BODY AND HER CURRENT IPG WAS IMPLANTED ON THE LEFT SIDE OF THE BODY. IT WAS UNCLEAR WHICH LEADS WERE INTERTWINED AND ¿BROKEN AND LOOSE.¿ REFER TO MANUFACTURER REPORT # 3004209178-2013-07970 REGARDING THE LEFT/CURRENT IPG.
IT WAS REPORTED THAT PATIENT HAD AN X-RAY TAKEN OF THEIR ¿PREVIOUS¿ IMPLANTABLE NEUROSTIMULATOR (INS) WHICH SHOWED THAT THE 2 LEADS WERE ¿TOTALLY INTERTWINED¿ AND WERE ¿BROKEN AND LOOSE.¿ THE PATIENTS STATED THAT THE LEADS ARE ¿NOT VERY GOOD AT ALL¿ AND WERE A ¿MESS.¿ IT WAS ALSO STATED THAT ¿THERE IS A WIRE MUMBO-JUMBO GOING ON RIGHT NOW.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222534 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |