FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1930035
·
Received November 18, 2010
Report
- Report Number
- 3004209178-2010-09756
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- September 1, 2010
- Report Date
- November 12, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PT HAD PAIN AROUND THE IMPLANTED DEVICE SITE AND TAILBONE. THE PT HAD THE DEVICE OFF FOR THE PAST TWO MONTHS AND SAID THAT ONLY TWO PROGRAMS WORK AND THE OTHER TWO ONLY GIVE PRESSURE IN TAILBONE. THE DEVICE WOULD FLIP WHILE THE PT WAS SLEEPING AT NIGHT. PT WAS TOLD THAT THE ONLY WAY TO FIX THE FLIPPING OF THE DEVICE WAS TO HAVE SURGERY AND THEY WON'T HAVE SURGERY. PT LAST HAD REPROGRAMMING DONE BY THE COMPANY REP AND THAT WORKED UNTIL OCTOBER. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | EXTENSION: MODEL 3095, LOT #: NAH035990V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT #: V162088| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT #: NJD052195N |