ENTERRA
Report
- Report Number
- 3004209178-2016-26645
- Event Type
- Injury
- Date Received
- December 16, 2016
- Date of Event
- November 17, 2016
- Report Date
- August 24, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- UDI-DI
- 00643169360686
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
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.
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT PRODUCTS: PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).
PRODUCT ANALYSIS (B)(4):ANALYSIS INFORMATION --(B)(6)2017 12:04:40 CST PLI# 10 PRODUCT ID# 37800 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S) AND TEST RESULTS. THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING. THE INS PASSED THE FINAL FUNCTIONAL TEST ON THE AUTOMATED TEST CONSOLE. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON THE ELECTRODE PAIRS THE INS HAD WHEN IT WAS RECEIVED. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS. ANALYSIS DETERMINED THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. ANALYSIS DETERMINED THE TELEMETRY WAS ACCEPTABLE. PRODUCT ID 4351-35 SERIAL# (B)(4) IMPLANTED: (B)(6)2016: PRODUCT TYPE LEAD. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED EVER SINCE SHE WAS IMPLANTED, SHE HAS HAD NOTHING BUT ISSUES WITH HER DEVICE. SHE NOTED THAT ONE OF HER LEADS HAD COME UNDONE, WHICH WAS WHEN THE PAIN STARTED SOMETIME IN (B)(6) 2016. SHE WAS IN A LOT OF PAIN AND FINALLY GOT A REVISION SURGERY SCHEDULED IN (B)(6) 2016. THE HCP SCANNED HER PRIOR TO HER REVISION AND TOLD HER THAT HER STOMACH WAS REALLY BAD AND HAD 20 ULCERS. SHE NOTED THAT IF ANYTHING TOUCHED HER STOMACH, IT WOULD START BLEEDING.
NO NEW INFORMATION RECEIVED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE REP REPORTED THAT THE PATIENT CAME INTO THE CLINIC FOR A NORMAL FOLLOW UP AND WAS NOTICED THAT IMPEDANCES WERE OUT OF RANGE. THE HEALTHCARE PROFESSIONAL (HCP) PERFORMED A SECONDARY LEAD CHECK AND WAS ABLE TO DETERMINE THAT THERE WAS AN ISSUE WITH LEAD 3. IT WAS NOTED TO BE GREATER THAN 20,000, MEANING THERE WAS A BREAK IN THE CIRCUIT. THE REP ALSO REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SYMPTOMS. THE REP REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831288 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37800 | 00643169360686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |