SOLETRA
Report
- Report Number
- 3004209178-2015-16427
- Event Type
- Malfunction
- Date Received
- August 20, 2015
- Report Date
- September 12, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
THE IMPLANTABLE NEUROSTIMULATOR (INS) REACHED NORMAL END OF LIFE; THERE WAS NO TELEMETRY AND NO OUTPUT. THE VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE EPOXY BOND WAS BROKEN BETWEEN THE HYBRID AND THE POSITIVE / NEGATIVE BATTERY TERMINAL. THE BATTERY VOLTAGE PRIOR TO DISCONNECTING THE DEVICE WAS 0.197 VOLTS. A LONGEVITY ESTIMATE WAS PERFORMED BASED ON THE SETTINGS USED WHEN THE DEVICE WAS RECEIVED AND RESULTED IN AN ESTIMATION OF 60 MONTHS. THE SETTINGS INCLUDED AMPLITUDE: 2.5V; RATE 185 HZ; PULSE WIDTH: 90 USEC, IMPEDANCES 1000 OHMS (DEFAULT IMPEDANCES AS NO IMPEDANCE VALUES WERE PROVIDED). IN SUMMARY, THERE WERE NO ELECTRICAL ANOMALIES FOUND WITH THE HYBRID CIRCUIT; THE INS WAS FOUND TO BE DEPLETED. 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: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR . PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2015 WITH THEIR DOCTOR. AS FAR AS THE BATTERY DEPLETION, HE FELT THAT THE PATIENT'S SETTINGS WERE TOO HIGH AND THAT WAS WHY ONE BATTERY ONLY LASTED TWO YEARS. HE WAS NOT AWARE OF MALFUNCTION BUT JUST HIGH SETTINGS. NO THERAPY CONCERNS WERE MENTIONED.
THE CONSUMER REPORTED THAT THEY HAD SEEN AN END OF LIFE (EOL) ERROR MESSAGE ON THE PATIENT PROGRAMMER AND IT HAD SUBSEQUENTLY BEEN CONFIRMED IN THE HEALTH CARE PROVIDER (HCP) OFFICE THAT THE RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) HAD DEPLETED. THE BATTERY HAD BEEN DEAD FOR OVER A YEAR, BUT THE CONSUMER DID NOT REMEMBER PRECISELY WHEN THE ERROR MESSAGE WAS SEEN. THE REPORTER STATED THAT IT WAS DISAPPOINTING THAT THE INS DIED SOONER THAN IT WAS SUPPOSED TO. IT WAS REPORTEDLY THOUGHT THAT THE DEVICE SHOULD LAST 4-6 YEARS, BUT IT LASTED APPROXIMATELY 2 YEARS. IT WAS ALSO REPORTED THAT THE HCP HAD NOTICED THE LEFT INS BATTERY WAS LOW/WEAK ON (B)(6) 2015; THE VOLTAGE WAS GETTING LOW. FIVE MONTHS LATER THE HCP CHECKED AGAIN AND NOTICED IT WAS GETTING LOWER. THERE HAD BEEN AN INS LOW CODE. NO SYMPTOMS WERE REPORTED. NO INTERVENTIONS OR TROUBLESHOOTING WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. INDICATIONS FOR USE: PARKINSONS DUAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553347 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR |