ACTIVA
Report
- Report Number
- 3004209178-2018-17304
- Event Type
- Injury
- Date Received
- August 2, 2018
- Date of Event
- July 18, 2014
- Report Date
- October 19, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00613994934604
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID 3389S-40 LOT# V080811, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. PRODUCT ID 3389S-40, LOT# V080811, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 12-DEC-2010, UDI#: (B)(4); PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: 12-DEC-2010, UDI#: (B)(4); PRODUCT ID: 37085-95, SERIAL/LOT #: (B)(4), UBD: 15-NOV-2014, UDI#: (B)(4); PRODUCT ID: 37085-95, SERIAL/LOT #: (B)(4), UBD: 29-NOV-2014, UDI#:(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. THE PATIENT FELL AND HIT THEIR HEAD DUE TO DIFFICULTY SWALLOWING FOOD AND BREATHING. A WEEK AFTER THIS EVENT, THE HOSPITAL WAS NOTIFIED OF EXPOSED LEADS AT THE SITE OF THE HEAD IMPACT FROM FALL. THE PATIENT HAD BEEN PICKING AT THE WOUND. THE DEVICE DIAGNOSIS WAS LEAD MIGRATION/DISLODGEMENT AND THE CLINICAL DIAGNOSIS WAS EXPOSED LEADS. THE ENTIRE DBS SYSTEM WAS REMOVED ON (B)(6) 2014 DUE TO CONTAMINATION FROM BEING EXPOSED. INFECTION WAS NOT CONFIRMED WITH TESTING, AND NO INFECTIONS WERE NOTED POST-OPERATIVELY. THE PATIENT RECOVERED WELL, BUT IT WAS NOT SPECIFIED IF THE EVENT WAS RESOLVED. THE EVENT RESULTED IN IN-PATIENT/PROLONGED HOSPITALIZATION AND MEDICAL/SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY INDICATED A HEAD CT SCAN WAS PERFORMED ON (B)(6) 2014 WITH NO ACUTE INTRACRANIAL FINDINGS. THE ETIOLOGY WAS STATED TO BE RELATED TO THE DEVICE/THERAPY. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
NO ADDITIONAL INFORMATION WAS RECEIVED.
ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY INDICATED THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587251 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 | 00613994934604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |