FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3944836
·
Received July 18, 2014
Report
- Report Number
- 3004209178-2014-13264
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- June 29, 2012
- Report Date
- June 25, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V302550, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THE POSTERIOR ¿SCP¿ ELEVATION REFERRED TO A SACROCOLPOPEXY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS GRADE III RECTOCELE. IT WAS NOTED THAT HE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2012. IT WAS NOTED THAT THE POSTERIOR ¿SCP¿ WAS ELEVATED. IT WAS NOTED THAT INTERVENTIONS INCLUDED SURGICAL TREATMENT. IT WAS NOTED THAT THE ETIOLOGY WAS NEW ILLNESS, INJURY. IT WAS NOTED THAT SIGNS AND SYMPTOMS INCLUDED INCOMPLETE BOWEL EVACUATION. IT WAS NOTED THAT THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422610 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R |