NA
Report
- Report Number
- 3006630150-2021-00481
- Event Type
- Injury
- Date Received
- February 15, 2021
- Date of Event
- January 15, 2021
- Report Date
- October 7, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI; UPN: M365DB12000; MODEL: DB-1200; SERIAL: (B)(6); LOT: 7741044. PRODUCT FAMILY: UPN: M365DB12000; MODEL: DB-1200; SERIAL: (B)(6); LOT: 743959. PRODUCT FAMILY: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); LOT: 7080981. PRODUCT FAMILY: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); LOT: 7081059.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12000, MODEL: DB-1200, SERIAL: (B)(6), LOT: 7741044. PRODUCT FAMILY: UPN: M365DB12000, MODEL: DB-1200, SERIAL: (B)(6), LOT: (B)(6). PRODUCT FAMILY: UPN: M365NM3138550, MODEL: NM-3138-55 , SERIAL: (B)(6), LOT: (B)(6). PRODUCT FAMILY: UPN: M365NM3138550, MODEL: NM-3138-55 , SERIAL: (B)(6), LOT: (B)(6). THE TWO LEAD EXTENSIONS RETURNED, NM-3138-55 SERIAL NUMBER: (B)(6) AND SERIAL NUMBER: (B)(6)WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED IPG, DB-1200 SERIAL NUMBER: (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A PRODUCT LABELING REVIEW FOR THESE DEVICES IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE IFU PRODUCT LABEL. ADDITIONALLY, THIS REVIEW IDENTIFIED THAT AN ALLERGIC OR IMMUNE SYSTEM RESPONSE TO IMPLANTED MATERIALS AND, OR IMPLANT SITE COMPLICATIONS SUCH AS PAIN, POOR HEALING, REDNESS, WARMTH, SWELLING OR WOUND REOPENING ARE KNOWN RISKS WITH USE OF THE DEEP BRAIN STIMULATION SYSTEM, AS DOCUMENTED IN THE IFU.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION PATIENT EXPERIENCED A RED REACTION AT THE POCKET SITE AND NECK AREA WHERE THE LEAD EXTENSION IS IMPLANTED. THE PHYSICIAN NOTED THIS MAY BE AN ALLERGIC REACTION TO THE DEVICES AND ADMINISTERED ANTIBIOTICS. THE PATIENT THEN UNDERWENT A LEAD EXTENSION REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED TO AVOID ANOTHER REACTION AND MOVED TO THE OTHER SIDE OF THE CHEST. THE PATIENT IS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONTINUED TO HAVE THE ALLERGIC BODY REACTION OF PAIN, EDEMA, AND INFLAMMATION AT THE IMPLANT SITES. THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2021 WHERE THE IMPLANTABLE PULSE GENERATOR AND LEAD EXTENSIONS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION PATIENT EXPERIENCED A RED REACTION AT THE POCKET SITE AND NECK AREA WHERE THE LEAD EXTENSION IS IMPLANTED. THE PHYSICIAN NOTED THIS MAY BE AN ALLERGIC REACTION TO THE DEVICES AND ADMINISTERED ANTIBIOTICS. THE PATIENT THEN UNDERWENT A LEAD EXTENSION REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED TO AVOID ANOTHER REACTION AND MOVED TO THE OTHER SIDE OF THE CHEST. THE PATIENT IS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONTINUED TO HAVE THE ALLERGIC BODY REACTION OF PAIN, EDEMA, AND INFLAMMATION AT THE IMPLANT SITES. THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6) 2021 WHERE THE IMPLANTABLE PULSE GENERATOR AND LEAD EXTENSIONS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED BY THE MEDICAL FACILITY.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: (B)(4), MODEL: DB-1200, SERIAL: (B)(4), LOT: 7741044.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION PATIENT EXPERIENCED A RED REACTION AT THE POCKET SITE AND NECK AREA WHERE THE LEAD EXTENSION WAS IMPLANTED. THE PHYSICIAN NOTED THIS MAY BE AN ALLERGIC REACTION TO THE DEVICE AND ADMINISTERED ANTIBIOTICS. THE PATIENT THEN UNDERWENT A LEAD EXTENSION REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS REPLACED TO AVOID ANOTHER REACTION AND MOVED TO THE OTHER SIDE OF THE CHEST. THE PATIENT IS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223981 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | NM-3138-55 | 7070163 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |