FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3358642
·
Received September 19, 2013
Report
- Report Number
- 3004209178-2013-16621
- Event Type
- Injury
- Date Received
- September 19, 2013
- Report Date
- August 26, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V872660, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE CALLER HAD A LOSS OF THERAPEUTIC EFFECT, AND THE THERAPY HAD NOT WORKED FOR THREE DAYS PRIOR TO REPORT. IT WAS STATED THE PATIENT DID NOT FEEL THE STIMULATION AND WAS UNABLE TO VOID. IT WAS NOTED THE PATIENT WAS IN THE HOSPITAL AND THE NURSE USED A CATHETER ON THE PATIENT. REPORTEDLY THE PROGRAMMER WOULD NOT COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT PLANNED TO SEE THE DOCTOR THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474300 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention |