SOLETRA
Report
- Report Number
- 3004209178-2013-17348
- Event Type
- Injury
- Date Received
- October 2, 2013
- Report Date
- September 11, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V120700, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V012723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).
SERIAL NUMBER CORRECTED TO (B)(4). CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V120700, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V012723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR.
(B)(4).
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND THE BATTERY WAS AT NORMAL END OF LIFE AND THERE WAS NO TELEMETRY OR OUTPUT. ANALYSIS OF THE EXTENSION FOUND THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
IT WAS REPORTED THAT THERE WAS A LEAD FRACTURE ABOVE THE CONNECTOR TO THE EXTENSION. IT WAS NOTED THAT THE EXTENSION/LEAD CONNECTOR SHOWED IN NECK AREA ON THE X-RAY. IT WAS FURTHER NOTED THAT IT WAS NOT IMPLANTED IN NECK. THERE WERE NO FALLS OR INJURY THAT THE PATIENT KNEW OF. THE LEAD WAS EXPLANTED AND REPLACED. IMPEDANCE TESTING AND X-RAYS WERE TROUBLESHOOTING PERFORMED. IMPEDANCE TESTING SHOWED GREATER THAN 2000 OHMS ON ALL 4 MONOPOLAR CONTACTS. PATIENT WAS ALIVE WITH NO INJURY. PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT WERE UNKNOWN. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT REQUIRED HOSPITALIZATION AND THE PATIENT OUTCOME WAS NO INJURY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS DAMAGED DURING THE EXPLANT PROCESS. THERE WAS NOT FURTHER INFORMATION REGARDING THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO AN ACCIDENT. IT WAS NOTED THAT THE EVENT WAS ATTRIBUTED TO THE LEAD AND EXTENSION. IT WAS NOTED THAT THERE WAS A BREAK AND DISLODGMENT/MIGRATION. IT WAS NOTED THAT THERE WAS AN EXPLANT AND REPLACEMENT OF THE LEAD AND EXTENSION ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497059 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00041 YR | Hospitalization| R |