FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3875192
·
Received June 16, 2014
Report
- Report Number
- 3007566237-2014-01668
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH IMPEDANCES WERE FOUND ON THE PATIENT¿S RIGHT DEEP BRAIN STIMULATION (DBS) SYSTEM. HIGH IMPEDANCES WERE MEASURED ON CONTACTS 0 AND 3. SURGERY WAS PERFORMED ON (B)(6) 2014. IMPEDANCE TESTING ON THE LEAD ALONE USING A SCREENING CABLE FOUND NORMAL IMPEDANCES. THE EXTENSION WAS THEN REPLACED AFTER WHICH IMPEDANCES WERE FOUND TO BE NORMAL. THERE WAS NO HEALTH HAZARD TO THE PATIENT. IT WAS NOTED THAT WHEN THE OLD EXTENSION WAS REMOVED, THE SCREW FROM THE LEAD-EXTENSION CONNECTION CAME OFF EXTERNALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352258 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |