FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2970239
·
Received February 20, 2013
Report
- Report Number
- 3007566237-2013-00554
- Event Type
- Injury
- Date Received
- February 20, 2013
- Report Date
- January 31, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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 3550S-01, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3389S-40, LOT# VA02PXP, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS SUCCESSFULLY PROGRAMMED BY THE HEALTHCARE PROVIDER (HCP).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT LEAD MIGRATION HAD OCCURRED POST-OP. MORE THAN TWO WEEKS LATER IT WAS STATED THAT POST-OP CT SCAN SHOWED THE LEAD MOVED ABOUT 15MM SUPERIOR ON (B)(6) 2013. NO MALFUNCTIONS WERE SEEN AND NO CAUSE OF THE ISSUE WAS DETERMINED. THE LEAD WAS REPOSITIONED TO THE INTENDED TARGET ONE DAY AFTER THE CT SCAN. INITIAL PROGRAMMING WAS SCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73095 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |