FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3120738
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-07927
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3093-28 LOT# VA03L5M, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S POCKET ERODED TO WHERE THE BATTERY WAS CAUSING PAIN. THE PATIENT¿S PHYSICIAN WAS GOING TO DO A POCKET REVISION, BUT BECAUSE THE BATTERY WAS TOO CLOSE TO THE SKIN AND TO MINIMIZE THE CHANCE OF INFECTION, THE PHYSICIAN REPLACED IT. THE PATIENT¿S SYMPTOMS WERE NOTED AS PAIN AND REDNESS AT THE POCKET SITE. IT WAS NOTED THAT THE PATIENT'S STATUS WAS ALIVE, WITH NO INJURY/ADVERSE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222601 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |