FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2181393
·
Received July 1, 2011
Report
- Report Number
- 3004209178-2011-05011
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Report Date
- June 6, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELL AND HER IMPLANTED NEUROSTIMULATOR DID NOT WORK AS WELL FOLLOWING THE FALL. IT WAS BELIEVED THAT THE LEADS MAY HAVE "CHANGED" OR THE BATTERY MAY HAVE BEEN DEPLETED. IT WAS ALSO REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION. WHEN STIMULATION WAS INCREASED, THE LOW BATTERY ICON APPEARED. THE PT HAD STIMULATION TURNED ON 24X7 AND THE BATTERY WAS AT 7.5 VOLTS. THE MFR WAS ABLE TO RECHARGE AND REPROGRAM THE DEVICE ON (B)(6) 2011. THE PHYSICIAN WAS GOING TO SET UP AN APPOINTMENT AND CHECK THE LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROGRAMMER: MODEL 3037, LOT# NJD091987N| LEAD: MODEL 3889, LOT# V251860| IMPLANTED:| EXPLANTED: |