FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2810368
·
Received October 31, 2012
Report
- Report Number
- 3007566237-2012-02596
- Event Type
- Injury
- Date Received
- October 31, 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
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A LEAD WAS DAMAGED DURING AN EXPLANT PROCEDURE AND A LEAD FRAGMENT REMAINED IN THE PATIENT. THERE WERE NO PATIENT SY MPTOMS/INJURIES RELATED TO THE EVENT. AN X-RAY WAS PERFORMED AND IT WAS DETERMINED THE LEAD FRAGMENT WAS SMALLER THAN 3 CENTIMETERS. THE PATIENT'S DEVICE WAS REMOVED AND SHE IS DOING 'FINE.'
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 |