ENTERRA
Report
- Report Number
- 3007566237-2013-01460
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- January 29, 2013
- Report Date
- April 3, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3116, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
(B)(4).
(B)(4).
REPORTED EVENTS: 2 PATIENTS EXPERIENCED SMALL BOWEL OBSTRUCTIONS; 2 PATIENTS EXPERIENCED SMALL BOWEL OBSTRUCTIONS RELATED TO THE DEVICE WIRES REQUIRING REMOVAL AND LAPAROTOMY; 1 PATIENT UNDERWENT TAKEDOWN SURGERY FOR ENTEROCUTANEOUS FISTULA.
KELLER, D. S., PARKMAN, H. P., BOUCEK, D. O., SANKINENI, A., MEILAHN, J. E., GAUGHAN, J. P., HARBISON, S. SURGICAL OUTCOMES AFTER GASTRIC ELECTRIC STIMULATOR PLACEMENT FOR REFRACTORY GASTROPARESIS. JOURNAL OF GASTROINTESTINAL SURGERY : OFFICIAL JOURNAL OF THE SOCIETY FOR SURGERY OF THE ALIMENTARY TRACT. 2013;17(4):620-626. DOI: 10.1007/S11605-013-2147-Z. SUMMARY: A RETROSPECTIVE REVIEW WAS PERFORMED FOR PATIENTS UNDERGOING ENTERRA GES (MEDTRONIC, INC.) PLACEMENT FOR REFRACTORY GASTROPARESIS FROM OCTOBER 2000 TO OCTOBER 2011. THE MAIN OUTCOME MEASURES WERE THE NEED/INDICATIONS FOR ADDITIONAL PROCEDURES AND SYMPTOM IMPROVEMENT. A TOTAL OF 266 PATIENTS HAD A GES IMPLANTED; 233 HAD COMPLETE RECORDS AND WERE INCLUDED IN THE ANALYSIS. FIFTY-EIGHT PERCENT (N=135) REQUIRED AN ADDITIONAL PROCEDURE AFTER GES PLACEMENT. NUTRITION ACCESS (45 PATIENTS REQUIRING 77 PROCEDURES) AND SUBCUTANEOUS POCKET ISSUES (N=21) WERE THE MOST COMMON INDICATIONS FOR SUBSEQUENT PROCEDURES. TWELVE PERCENT (N=29) HAD THE GES EXPLANTED, MAINLY FOR CONTINUED GASTROPARETIC SYMPTOMS (N=11), MECHANICAL ISSUES (N=9), OR INFECTION (N=4). NINETY PATIENTS HAD SUBSEQUENT HOSPITALIZATIONS, MAINLY FOR GASTROPARETIC FLARES. MORTALITY DURING THE FOLLOW-UP PERIOD WAS 2.1 %. BMI WAS PREDICTIVE OF ADDITIONAL SURGICAL PROCEDURE: WHEN OVERWEIGHT, THE RISK OF POCKET REVISION INCREASED 4.45 TIMES (OR=4.452). OF 74 MOST RECENT PATIENTS WITH PROSPECTIVE LONG-TERM OUTCOME DATA, 70 % REPORTED IMPROVED SYMPTOMS OF PAIN, BLOATING, AND NAUSEA. ALTHOUGH MOST PATIENTS REPORTED SYMPTOMATIC IMPROVEMENT AFTERGES IMPLANTATION, THERE IS OFTEN A NEED FOR ADDITIONAL SURGICAL PROCEDURES AS WELL AS ASSOCIATED COMPLICATIONS AFTER GES PLACEMENT. ADDITIONAL PROCEDURES WERE MOST FREQUENT FOR SURGICAL NUTRITION AND SUBCUTANEOUS POCKET ISSUES; POCKET REVISIONS WERE MORE FREQUENT IN OBESE PATIENTS. FROM OUR RESULTS, WE AMENDED OUR PRACTICE TO ADD A JEJUNOSTOMY TUBE IN MALNOURISHED PATIENTS AND SUTURE THE STIMULATOR TO THE SUBCUTANEOUS POCKET FASCIA. FURTHER STUDIES WILL DETERMINE IF THESE CHANGES REDUCE THE RATE OF COMPLICATIONS AND ADDITIONAL PROCEDURES AFTER GES PLACEMENT. REPORTED EVENTS: 90 OF THE 233 PATIENTS HAD SUBSEQUENT READMISSIONS FOR GASTROPARESIS EXACERBATION. FIVE PATIENTS EXPERIENCED WOULD INFECTION. FOUR OF THE 5 PATIENTS UNDERWENT EXPLANT OF THE GES. ONE PATIENT EXPERIENCED A SUTURE GRANULOMA. TWENTY-ONE PATIENTS UNDERWENT REVISION OF THE STIMULATOR IN SUBCUTANEOUS POCKET. FOUR PATIENTS UNDERWENT INCISIONAL HERNIA REPAIR. TWO PATIENTS EXPERIENCED LEAD EROSION REQUIRING REVISION. ELEVEN PATIENTS UNDERWENT EXPLANT OF THEIR GES DUE TO NO RELIEF OF SYMPTOMS. NINE PATIENTS UNDERWENT EXPLANT OF GES DUE TO MECHANICAL DEVICE ISSUES. THREE PATIENTS UNDERWENT EXPLANT OF GES DUE TO STIMULATOR EROSION THROUGH SKIN. ONE PATIENT EXPERIENCED WIRE PENETRATION INTO THE GASTRIC LUMEN FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION: REPORTED EVENTS: 11. 4 PATIENTS EXPERIENCED SMALL BOWEL OBSTRUCTIONS, 2 OF WHICH REQUIRED A SURGICAL LAPAROTOMY. 12. 1 PATIENT UNDERWENT TAKEDOWN SURGERY FOR ENTEROCUTANEOUS FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184629 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |