INTERSTIM II
Report
- Report Number
- 3004209178-2013-07646
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- May 7, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V855059, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3093-28, LOT# V855059, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT WAS "NOT HAVING NORMAL BOWEL MOVEMENTS" AND TOO MANY "PELLETS." THE PATIENT REPORTEDLY MET WITH THEIR HEALTHCARE PROVIDER (HCP) 2 MONTHS AGO AND THEY FELT "SOMETHING WASN'T RIGHT" AND ORDERED A PELVIC X-RAY TO MAKE SURE THE "PROBE HAD NOT SLIPPED." IT WAS LATER REPORTED THAT THE X-RAY SHOWED THE PREVIOUS LEAD MIGRATED, SO RE-IMPLANTATION OF THE LEAD WAS PERFORMED. IT WAS REPORTED THE PATIENT WAS CURRENTLY RECEIVING EFFECTIVE THERAPY. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.
FOLLOW UP INFORMATION OBTAINED FROM THE PHYSICIAN ATTRIBUTED THE PATIENT¿S DIARRHEA TO ANTIBIOTIC USE. IT WAS ALSO REPORTED THAT THE PATIENT HAD COLITIS, C. DIFFICILE, AND CHRONIC DIARRHEA. IN ADDITION, A REVISION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PERFORMED ON (B)(6) 2013. HOSPITALIZATION WAS NOT REQUIRED FOR THE EVENT. NO INJURIES WERE NOTED AND THE PATIENT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY/ILLNESS. IF ADDITIONAL INFORMATION IS RECEIVED, FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213194 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |