SOLETRA
Report
- Report Number
- 3004209178-2014-12714
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Report Date
- June 17, 2014
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V402883, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V043266, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), PRODUCT TYPE EXTENSION. (B)(4).
PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V402883, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V043266; PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4); PRODUCT TYPE EXTENSION.
PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V402883, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V043266, PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD TROUBLE AT AIRPORTS AND HAD ALWAYS HAD THEM PAT HER DOWN BECAUSE, IF SHE WAS NEAR THE MACHINES THEY USED SHE WOULD GET A TERRIBLE HEADACHE AND HAD GOTTEN THEM SINCE HER FIRST IMPLANT IN 2007. IT WAS NOTED THAT THE PATIENT HAD TRIED TO STAY OUT OF LINE OF THE ENTRANCE AND EXITS OF THE MACHINES BUT THAT SOMETIMES DID NOT HELP. THE PATIENT WAS IN A WHEELCHAIR. IT WAS NOTED THAT ONE TIME THE SECURITY MACHINES HAD TURNED HER STIMULATION OFF AT THE AIRPORT. IT WAS UNKNOWN WHEN THAT WAS BUT IT MIGHT HAVE BEEN IN 2007. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-12713.
IT WAS LATER REPORTED THAT WHENEVER THE PATIENT WENT THROUGH THE (B)(4) AIRPORT SHE WOULD BE AFFECTED BY THE SECURITY SCREENERS IF SHE GOT CLOSE TO IT. THE PATIENT WOULD GET SOME SORT OF REACTION IN HER HEAD, LIKE THERE WAS PRESSURE. THE PATIENT WENT THROUGH THE AIRPORT TWICE A YEAR. THE PATIENT EXPERIENCED SHAKING WHEN THE IMPLANT WAS TURNED OFF. NO INTERVENTIONS OR OUTCOMES WERE PROVIDED REGARDING THIS EVENT. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401914 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |