FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2809072
·
Received October 30, 2012
Report
- Report Number
- 3004209178-2012-09724
- Event Type
- Injury
- Date Received
- October 30, 2012
- Report Date
- October 2, 2012
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3889-28, LOT# V933650, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT'S IMPLANT SURGERY WAS "DIFFICULT AND TOOK OVER 2 HOURS." IT WAS NOTED THE PATIENT "HAD SO MUCH ARTHRITIS AND SCAR TISSUE." IT WAS ALSO REPORTED, THE PATIENT EXPERIENCED PAIN WHEN A NERVE WAS HIT DURING THE PROCEDURE. THE PATIENT REPORTED BEING PROBED OVER 20 TIMES. IT WAS ALSO REPORTED, THE PHYSICIAN HAD TO GO TO THE LEFT SIDE OF THE PATIENT'S BACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |