INTERSTIM II
Report
- Report Number
- 3004209178-2017-13733
- Event Type
- Injury
- Date Received
- June 26, 2017
- Date of Event
- May 31, 2017
- Report Date
- June 26, 2017
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- UDI-DI
- 00613994287724
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V230971, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. (B)(4) APPLIES TO LEAD (LOT# V230971) ONLY.
INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. WHEN REMOVING THE LEAD FROM THE EXTENSION, THE LEAD ELECTRODE #3 WAS DAMAGED AND UNABLE TO BE SEATED IN THE NEW INS. ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THIS ISSUE ARE NOT KNOWN. THE HCP ATTEMPTED SEVERAL TIMES TO PLACE THE LEAD IN THE NEW INS, BUT WAS UNABLE. A NEW LEAD WAS PLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449629 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 | 00613994287724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |