FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2850542
·
Received November 29, 2012
Report
- Report Number
- 3004209178-2012-10907
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- November 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD SHOWED THE STIM LEAD CONDUCTOR WAS BROKEN AT THE ANCHOR SITE. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 3093-28 LOT# V979687, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4). PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALIES. ANALYSIS OF THE LEAD FOUND BROKEN CONDUCTORS, ANCHOR SITE WAS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPEDANCES WERE ALL OUT OF RANGE AND LEAD BROKE UPON REMOVAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD NEW IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD IMPLANTED AND WAS HAVING POSITIVE RESPONSE.
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 | 00071 YR | Required Intervention |