STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Report
- Report Number
- 3006630150-2018-62185
- Event Type
- Injury
- Date Received
- December 11, 2018
- Date of Event
- January 1, 2017
- Report Date
- February 13, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THE RETURNED IPG DB-1110C (SERIAL NUMBER: (B)(4)) WAS ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE LEADS DB-2201-30AC (SERIAL NUMBER: (B)(4)) AND DB-2201-30AC (SERIAL NUMBER: (B)(4)) INDICATED THAT THE LEAD BODY WAS CLEANLY CUT AND ON THE PROXIMAL SECTION OF THE LEAD WAS RETURNED. THE DISTAL END OF THE LEAD WAS NOT RETURNED. ELECTRICAL TESTING COULD NOT BE PERFORMED DUE TO THE SEVERE DAMAGE TO THE LEAD BODY. THE CUT DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. ANALYSIS OF THE CONTACT EXTENSIONS NM-3138-55 (SERIAL NUMBER: (B)(4)) AND NM-3138-55 (SERIAL NUMBER: (B)(4)) INDICATED THAT THE COMPLAINTS OF LOSS OF THERAPY, HIGH IMPEDANCE, AND LEAD DAMAGE HAVE BEEN CONFIRMED. VISUAL INSPECTION REVEALED THAT THE CONNECTOR/DISTAL END OF THE LEAD EXTENSION WAS SEPARATED FROM THE LEAD BODY AND TORN APART. IT APPEARS THAT EXCESSIVE TENSILE FORCE WAS EXERTED ONTO THE LEAD BODY AND CONNECTOR RESULTING IN THE SEPARATION OF THE CONNECTOR FROM THE LEAD BODY. THERE ARE EXPOSED CABLES AND ELECTRICAL TESTING COULD NOT BE PERFORMED DUE TO THE SEVERE DAMAGE TO THE LEAD BODY.
ADDITIONAL INFORMATION WAS RECEIVED THAT TWO LEADS WERE ALSO EXPLANTED DURING THE SAME PROCEDURE IN 2017. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2201-30AC SERIAL/LOT: (B)(4) DESCRIPTION: LEAD KIT 30 CM MODEL: DB-2201-30AC SERIAL/LOT: (B)(4) DESCRIPTION: LEAD KIT 30 CM
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES ON SEVERAL CONTACTS, WHICH RESULTED IN LOSS OF THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTICED THERE WAS A LEAD FRACTURE ON THE CONTACT EXTENSION. THE LEAD WAS TORN OUT AND SEPARATED FROM THE CONNECTION HEADER. THE IPG AND TWO CONTACT EXTENSIONS WERE ALSO EXPLANTED.
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES ON SEVERAL CONTACTS, WHICH RESULTED IN LOSS OF THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTICED THERE WAS A LEAD FRACTURE ON THE CONTACT EXTENSION. THE LEAD WAS TORN OUT AND SEPARATED FROM THE CONNECTION HEADER. THE IPG AND TWO CONTACT EXTENSIONS WERE ALSO EXPLANTED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: NM-3138-55, SERIAL/LOT: (B)(4), DESCRIPTION: 55CM 8 CONTACT EXTENSION. MODEL: DB-1110C, SERIAL/LOT: (B)(4), DESCRIPTION: VERCISE IPG.
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES ON SEVERAL CONTACTS, WHICH RESULTED IN LOSS OF THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTICED THERE WAS A LEAD FRACTURE ON THE CONTACT EXTENSION. THE LEAD WAS TORN OUT AND SEPARATED FROM THE CONNECTION HEADER. THE IPG AND TWO CONTACT EXTENSIONS WERE ALSO EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992234 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | NM-3138-55 | 16554699 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |