ENTERRA
Report
- Report Number
- 3007566237-2016-04008
- Event Type
- Injury
- Date Received
- November 10, 2016
- Date of Event
- October 17, 2016
- Report Date
- June 27, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2016-04008. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD.
PRODUCT ANALYSIS; PRODUCT ID#: 37800. THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING. ANALYSIS FOUND THAT THE INS WAS FUNCTIONALLY OKAY AND THERE WERE INSIGNIFICANT ANOMALIES. PRODUCT ID#: 4351-35: THE LEAD WAS RETURNED SEGMENTED; HOWEVER ELECTRICAL TESTING OF THE RETURNED SEGMENT(S) DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4) NO LONGER APPLIES TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PATIENT OUTCOME ATTRIBUTED TO THE ADVERSE EVENT, LABELED DISABILITY IS NO LONGER APPLICABLE TO THIS EVENT.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THE DEVICE WAS EXPLANTED ON (B)(6), ALTHOUGH IT WAS UNCLEAR IF THIS WAS THE CORRECT DATE.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT¿S SYSTEM WAS COMPLETELY REMOVED ON (B)(4) 2016.
THE HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS REFERRED TO THE HCP AND THEY DISCOVERED THE LEAD ENTANGLED IN THE BOWEL ON (B)(6) 2016. THE HCP DID NOT DO THE ORIGINAL IMPLANT. IT WAS UNKNOWN IF ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS LED TO THE EVENT. IT WAS UNKNOWN WHAT TROUBLESHOOTING WAS PERFORMED AND UNKNOWN WHAT ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE LEAD WAS REPLACED AND THE MANUFACTURER REPRESENTATIVE DIDN'T HAVE ALL THE DETAILS.
FURTHER INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE BOWEL OBSTRUCTION WAS SECONDARY TO THE STIMULATOR WIRE, CECAL VOLVULUS. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT EXPERIENCED A BOWEL OBSTRUCTION IN RELATION TO THE LEAD BECOMING ENTANGLED IN THE BOWEL. A CT SCAN WAS DONE AND DISCOVERED THE ISSUE. AN EXPLORATORY OPERATION WAS DONE TO RESECT INTESTINE NERVE. THEY NOTED THAT THE LEADS WERE BRED SUCH THIS SHORT LENGTH, HOWEVER, WITH ABDOMINAL DISTENTION, THE LEADS MAY HAVE LENGTHENED INTRA PERITONEAL. THE PATIENT HAD A BOWEL RESECTION AND REMOVAL OF THE LEADS REMOVED, NOTING THE ISSUE WAS RESOLVED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP. IT WAS REPORTED THAT THE SURGERY PERFORMED IN (B)(6) 2016 WAS A TOTAL EXPLANT. THE ENTIRE SYSTEM, LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS), WAS EXPLANTED ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744925 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Life Threatening| R| S |