FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2780829
·
Received October 10, 2012
Report
- Report Number
- 3004209178-2012-09069
- Event Type
- Injury
- Date Received
- October 10, 2012
- Report Date
- September 10, 2012
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V305208, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V305208, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ELECTRODE PAIR 0 <(>&<)> 3 ON THE LEFT SIDE HAD AN IMPEDANCE READING OF OVER 4,000 OHMS WHEN READ AT 1.5 V, 210 US, AND 30 HZ. IT WAS ALSO REPORTED THAT THE DEVICE WAS REPLACED. IT WAS NOTED THAT PRIOR TO THE REPLACEMENT THE THERAPY WAS "GOOD/NORMAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |