ACTIVA
Report
- Report Number
- 3004209178-2013-08627
- Event Type
- Injury
- Date Received
- June 4, 2013
- Report Date
- May 13, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS MRU. UPDATED/CORRECTED CONCOMITANT PRODUCTS: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
(B)(4).
PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V270501, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION.
CONCOMITANT PRODUCTS: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION.
ADDITIONAL REVIEW DETERMINED THAT THE EVENT WHERE THE PATIENT HIT HER HEAD WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 30042091 78-2013-08355. INFORMATION REGARDING THAT EVENT WILL BE REPORTED UNDER THAT MANUFACTURER REPORT NUMBER.
IT WAS REPORTED THAT THE PATIENT HAD A LEAD REPLACED IN (B)(6) 2013 DUE TO THE LEAD BEING CRACKED.
ADDITIONAL INFORMATION STATED, THE CAUSE OF THE EVENT WAS THAT THE PATIENT FELL AND HIT THEIR HEAD ON 2013 (B)(6). IT WAS STATED THERE WAS NO DETERIORATION IN DYSTONIA OR SUBSEQUENT SYMPTOMS AFTER THE FALL. IMPEDANCES WERE ALL OK. REPORTEDLY THE ISSUE WAS DUE TO THE EXTENSION AND THERE WERE ¿TWO HOLES IN CARING OVER THE WIRES¿ ON 2013 (B)(6). IT WAS ALSO STATED ON 2013 (B)(6) THE LEFT LEAD EXTENSION WAS REPLACED AND IMPEDANCES WERE NORMAL FOLLOWING REPLACEMENT. REPORTEDLY, THE PATIENT AND HIT THE LEAD ON THE PLAYGROUND ON 2013 (B)(6) AND THE PATIENT¿S MOTHER CALLED TO FOLLOW UP ON 2013 (B)(6) TO SAY THE PATIENT WAS OKAY AND RETURNED TO SCHOOL. SYMPTOMS ASSOCIATED WITH THE EVENT WERE PAIN FROM CHEST NEAR GENERATOR, AND PAIN DOWN LEFT ARM. HOSPITALIZATION WAS REQUIRED DUE TO THE EVENT.
IT WAS LATER REPORTED WIRE WAS REPLACED, THEY THOUGHT THERE WAS A MICRO FRACTURE IN THE WIRE. IT WAS NOTED THAT IT WAS NOT DETERMINED IF THERE WAS A MICRO FRACTURE IN THE WIRE. IT WAS FURTHER NOTED THAT THE PATIENTS SYMPTOMS GOT BETTER AFTER THE WIRE WAS REPLACED AND IMPEDANCES STAYED THE SAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245781 | ACTIVA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00009 YR | Hospitalization| R |