FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2587595
·
Received May 24, 2012
Report
- Report Number
- 3004209178-2012-03696
- Event Type
- Injury
- Date Received
- May 24, 2012
- Report Date
- April 29, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID (B)(4), LOT# V855059, SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED, PRODUCT TYPE: LEAD, PRODUCT ID (B)(4), LOT#, SERIAL # (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN STIMULATION WAS ON, THE PATIENT NEVER RECEIVED THERAPEUTIC EFFECT. ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS BELIEVED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED. THE CAUSE OF THE EVENT WAS NOTED AS OVERACTIVE BLADDER. THE INS WORKED AT FIRST, THEN DID NOT. NO HOSPITALIZATION WAS REQUIRED. PATIENT OUTCOME WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |