FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1913546
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09417
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 28, 2010
- 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
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A LACK OF STIMULATION SENSATION. THERE WS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS PROBLEM. THE HEALTH CARE PROFESSIONAL READ ">4000 OHMS ON SOME OF THE BIPOLAR PAIRS." THE PT WAS PROGRAMMED USING ELECTRODE 3 AND THE HCP CHANGED THE PT'S PROGRAMMING TO "2+,0-." THE PT INITIALLY FELT STIMULATION IN THE SAME AREA AFTER THIS REPROGRAMMING BUT THEN LOST STIMULATION AFTER 24 HOURS. THE HCP WANTED TO DELAY SURGERY IF THE IMPLANTABLE NEUROSTIMULATOR HAD GOOD LONGEVITY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 61 YR | IMPLANTED:| LEAD: MODEL 3889, LOT # V001516| EXTENSION: MODEL 3095, LOT # NAH028771V| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT # NGM026988P| LEAD: MODEL 3889, LOT # V001516| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |