ENTERRA
Report
- Report Number
- 3007566237-2012-02807
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 24, 2012
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 435135, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT ALL OF THE PATIENT'S SYMPTOMS HAD RETURNED AND THEY WERE ON A LIQUID ONLY DIET. IT WAS NOTED THAT THE PATIENT HAD LOST 20 POUNDS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS STILL 'FLIPPING' AND THE PATIENT STILL HAD TO WEAR A BINDER. IT WAS STATED THAT THE PATIENT SAW THEIR DOCTOR ON (B)(6) 2012 AND THE DOCTOR SAID 'EVERYTHING WAS WORKING.' NO FURTHER INFORMATION WAS PROVIDED. MORE INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
IT WAS REPORTED THAT THE PATIENT'S STIMULATOR WAS FLIPPING INSIDE OF THE POCKET. THE PATIENT DID NOT FEEL WELL FOLLOWING A BATTERY REPLACEMENT. THE PATIENT STATED THAT "EVERY TIME SHE GETS UP, THE DEVICE FLIPS", AND AFTER THE SURGERY THE DEVICE SITE STARTED TO SWELL AGAIN. THE PATIENT HAD LOST 15-20 POUNDS SINCE THE SURGERY BECAUSE SHE DID NOT WANT TO EAT, AND HER SYMPTOMS WERE NOT BEING CONTROLLED. THE PATIENT WAS TOLD BY HER PHYSICIAN THAT THE DEVICE WAS WORKING AS INTENDED, AND HE MADE ADJUSTMENTS TO HER SETTINGS. ONE WEEK LATER, ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS STILL WEARING A BINDER TO ADDRESS THE DEVICE FLIPPING. THE PATIENT WAS CONCERNED THAT ADDITIONAL FLIPPING COULD RESULT IN A SEROMA. THE PATIENT WAS TOLD BY ANOTHER PHYSICIAN THAT THE FLIPPING WAS "OKAY", AND HE ADVISED HER TO WEAR THE BINDER. THE PATIENT STATED THAT SHE HAD NOT RECEIVED ANY THERAPEUTIC RELIEF SINCE HER MOST RECENT IMPLANT. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A DEVICE REVISION. BEFORE THE PROCEDURE BEGAN, THE IMPEDANCES WERE CHECKED AND REPORTED AS 'NOT NORMAL.' THE DEVICE WAS FOUND TO BE CONTAINED WITHIN A SEROMA. THE SEROMA WAS ASPIRATED. BOTH SUTURES HOLDING THE DEVICE HAD BEEN DISRUPTED. THE WIRES WERE WRAPPED SEVERAL TIMES AROUND THEMSELVES ON THE MEDIAL SIDE OF THE BATTERY PACK. AFTER THE CERUMEN HAD BEEN EVACUATED, IMPEDANCES WERE RECHECKED AND FOUND TO BE SATISFACTORY. A BATTERY REPLACEMENT WAS NOT NECESSARY. THE BATTERY WAS SUTURED TO THE ANTERIOR FASCIA. WOUND WAS IRRIGATED WITH ANTIBIOTIC SOLUTION. FINAL IMPEDANCE CHECK WAS SATISFACTORY. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
FOLLOW UP REPORTED THE PATIENT'S NEW HEALTH CARE PROVIDER WOULD BE DOING A REVISION TO SECURE THE DEVICE IN THE POCKET BUT THEY WERE CURRENTLY WAITING ON APPROVAL FOR THE PROCEDURE. IT WAS NOTED THE PATIENT DID HAVE A VERY SMALL SEROMA THAT WOULD BE TAKEN CARE OF DURING THE REVISION. FURTHER FOLLOW UP REPORTED THE PATIENT HAD THE REVISION SURGERY AND WAS RECOVERING. THE SEROMA WAS DRAINED DURING THE REVISION. IT WAS NOTED THE PATIENT HAD A FOLLOW UP APPOINTMENT SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |