FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3232779
·
Received July 18, 2013
Report
- Report Number
- 3004209178-2013-11928
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- June 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELL AND ¿SHOCKED¿ HER BACK. SYMPTOMS OF OVER ACTIVE BLADDER (OAB) OCCURRED AND THE PATIENT WENT TO HER HEALTH CARE PROVIDER (HCP) WHERE THE IMPEDANCES WERE TESTED. AN X-RAY WAS ALSO TAKEN AND NO REPROGRAMMING OCCURRED. THE DEVICE DEFECT WAS A CONSEQUENCE OF THE FALL. AS PREVIOUSLY REPORTED THE SYSTEM WAS THEN REPLACED. THE PATIENT WAS OKAY WITH EFFECTIVE THERAPY.
Description of Event or Problem · 1
IT WAS REPORTED THAT ALL IMPEDANCES WERE GREATER THAN 4,000 OHMS AFTER A PATIENT ¿SHOCK.¿ THE PATIENT¿S DEVICE WAS REPLACED AND SHE WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335044 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |