FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1800018
·
Received August 12, 2010
Report
- Report Number
- 3004209178-2010-06076
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 14, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT BEGAN "ABOUT THREE WEEKS AGO." THE PT STATED THAT AT THIS TIME, THE URGE FREQUENCY RETURNED. THE PT REPORTED HAVING A NERVE BLOCK ON (B)(6)2010, AND AFTER THAT NOT BEING ABLE TO FEEL THE "TOE CURL" ON THE LEFT FOOT. THE PT ALSO FELL "ABOUT A MONTH AGO", BUT IT "WAS NOT A SERIOUS FALL". NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT # NGM017280P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# J0454962V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH018183V| IMPLANTED: |