FDA Adverse Event
Malfunction
Summary report: N
ACTIVA RC
MDR report key: 1923220
·
Received November 9, 2010
Report
- Report Number
- 3004209178-2010-09139
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 20, 2010
- Manufacturer
- MDT PUERTO RICO OPEARTIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED INTERMITTENT HEAD BOBBING. HE HAD A SHORT IN HIS LEFT SIDE IMPLANTABLE NEUROSTIMULATOR SYSTEM WHICH HAD BEEN PROGRAMMED AROUND. THE HEALTH CARE PROFESSIONAL EXAMINED THE SYSTEM AND NOTED: "RIGHT DONE AT 3.0V C/8 1426, C/9 1627, C/10 1779, C/11 1443, 8/9 2594, 8/10 3250, 8/11 2612, 9/10 2904, 9/11 2612, 10/11 2722." SHE ALSO REPORTED "4.4V, 240 PW, 60 RATE 11+ AND 9- WITH 2464 THERAPY IMPEDANCE." THE SYSTEM WAS PALPATED BUT THE RESULTS WERE NOT PROVIDED. THE HCP CONSIDERED TAKING X-RAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA RC | MHY | MDT PUERTO RICO OPEARTIONS CO., JUNCOS | 37612 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA125608N| EXPLANTED:| LEAD: MODEL 3387S, LOT# V01273| PROGRAMMER: MODEL 37642, LOT#NJZ100930N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN003185V| IMPLANTED: |