ACTIVA
Report
- Report Number
- 3004209178-2014-20114
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- August 15, 2014
- Report Date
- September 29, 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
- CH
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THE ESSENTIAL TREMOR PATIENT¿S ¿SYMPTOMS BEGAN TO APPEAR AGAIN¿ ON (B)(6) 2014. THE PATIENT¿S ¿LIMBS WERE TREMBLING AND HIS LEFT HAND FELT SORE.¿ THE CAUSE OF THE EVENT WAS UNKNOWN AND THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS UNKNOWN AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION REPORTED THE PATIENT WAS REPROGRAMMED A WEEK PRIOR TO FOLLOW-UP, AT WHICH TIME ¿THE SYMPTOM OF TREMBLING HAND IMPROVED.¿ HOWEVER, ¿THE PATIENT¿S HAND BEGAN TO SHAKE AGAIN¿ AT THE TIME OF FOLLOW-UP. FOUR DAYS AFTER FOLLOW-UP, ¿THE PATIENT¿S FEET HAD THE FEELING OF SHOCKING AFTER BATHING.¿ THE PATIENT NOTED THAT THIS ¿SYMPTOM NEVER HAPPENED AGAIN.¿ AS OF 2014-(B)(6) THE ¿PATIENT¿S HANDS WERE SHAKING¿ THE SAME AS THEY HAD PRIOR TO THE IMPLANT OF THEIR DEVICE AND THEIR ¿LEFT FOOT HAD NUMBNESS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667907 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR |