FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2833337
·
Received November 15, 2012
Report
- Report Number
- 3007566237-2012-02717
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_SCREWDRIVER, LOT# 082207412A, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_SCREWDRIVER, LOT# 082207412A, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_SCREWDRIVER, PRODUCT TYPE ACCESSORY; PRODUCT ID 924256, LOT# 082207412A, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS OF THE THREE SCREWDRIVER ACCESSORIES, LOT #082207412A, FOUND THE TIPS TWISTED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE TIGHTENING THE SCREWS OF A STIMLOC CAP, ONE OF THE SCREWS SNAPPED. A PAIR OF SURGICAL PLIERS WAS USED TO REMOVE THE BROKEN SCREW FROM THE PATIENT'S SKULL. A NEW STIMLOC KIT WAS USED AND THE BASE RING WAS SECURED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY AND HE FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR |