STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Report
- Report Number
- 3006630150-2025-02965
- Event Type
- Death
- Date Received
- May 1, 2025
- Date of Event
- April 7, 2025
- Report Date
- September 16, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729966340
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B2: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002609, UDI: (B)(4).
BLOCK B2: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002609. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
BLOCK B2: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT INITIALLY EXHIBITED STABLE POSTOPERATIVE PROGRESS. HOWEVER, WHILE IN THE POST-ANESTHESIA CARE UNIT, SHE AWOKE IN PAIN AND WAS ADMINISTERED PAIN MEDICATION, WHICH RESULTED IN RESPIRATORY ARREST, NECESSITATING INTUBATION. SUBSEQUENTLY, THE ATTENDING PHYSICIAN IDENTIFIED A SEVERE HEMORRHAGE WITH SIGNIFICANT BLOOD LOSS AND CHARACTERIZED THE CONDITION AS CRITICAL. THE PHYSICIAN DID NOT ATTRIBUTE THE COMPLICATION TO THE IMPLANTED HARDWARE. THE PATIENT WAS THEREAFTER HOSPITALIZED AND PLACED ON LIFE SUPPORT BUT, UNFORTUNATELY, LATER SUCCUMBED TO HER CONDITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED APPROXIMATELY 60 MINUTES AFTER THE PROCEDURE. THE PATIENT EXPERIENCED HEAD PAIN, AND THE CAUSE OF DEATH WAS DETERMINED TO BE HEMORRHAGE.
IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT INITIALLY EXHIBITED STABLE POSTOPERATIVE PROGRESS. HOWEVER, WHILE IN THE POST-ANESTHESIA CARE UNIT, SHE AWOKE IN PAIN AND WAS ADMINISTERED PAIN MEDICATION, WHICH RESULTED IN RESPIRATORY ARREST, NECESSITATING INTUBATION. SUBSEQUENTLY, THE ATTENDING PHYSICIAN IDENTIFIED A SEVERE HEMORRHAGE WITH SIGNIFICANT BLOOD LOSS AND CHARACTERIZED THE CONDITION AS CRITICAL. THE PHYSICIAN DID NOT ATTRIBUTE THE COMPLICATION TO THE IMPLANTED HARDWARE. THE PATIENT WAS THEREAFTER HOSPITALIZED AND PLACED ON LIFE SUPPORT BUT, UNFORTUNATELY, LATER SUCCUMBED TO HER CONDITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED APPROXIMATELY 60 MINUTES AFTER THE PROCEDURE. THE PATIENT EXPERIENCED HEAD PAIN, AND THE CAUSE OF DEATH WAS DETERMINED TO BE HEMORRHAGE.
IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT INITIALLY EXHIBITED STABLE POSTOPERATIVE PROGRESS. HOWEVER, WHILE IN THE POST-ANESTHESIA CARE UNIT, SHE AWOKE IN PAIN AND WAS ADMINISTERED PAIN MEDICATION, WHICH RESULTED IN RESPIRATORY ARREST, NECESSITATING INTUBATION. SUBSEQUENTLY, THE ATTENDING PHYSICIAN IDENTIFIED A SEVERE HEMORRHAGE WITH SIGNIFICANT BLOOD LOSS AND CHARACTERIZED THE CONDITION AS CRITICAL. THE PHYSICIAN DID NOT ATTRIBUTE THE COMPLICATION TO THE IMPLANTED HARDWARE. THE PATIENT WAS THEREAFTER HOSPITALIZED AND PLACED ON LIFE SUPPORT BUT, UNFORTUNATELY, LATER SUCCUMBED TO HER CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1071779 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2203-45 | 5002416 | 08714729966340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Death| H |