ACTIVA

MDR report key: 2821762 · Received November 6, 2012

Report

Report Number: 3004209178-2012-09979
Event Type: Injury
Date Received: November 6, 2012
Report Date: October 8, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # VA005VQ, PRODUCT TYPE LEAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT ABOUT 1.5 WEEKS AGO THE PATIENT'S PHYSICIAN ATTEMPTED TO PLACE A SECOND LEAD; HOWEVER, THE PHYSICIAN HAD TO ABORT THE SURGERY DUE TO SLIGHT BLEEDING AND WILL ATTEMPT AT A LATER DATE. IT WAS UNKNOWN WHETHER UNIPOLAR CAUTERY WAS USED DURING SURGERY. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE BLEEDING WAS WITHIN THE CRANIUM. THE CAUSE OF THE BLEEDING WAS UNDETERMINED AND OCCURRED ALMOST IMMEDIATELY AFTER THE BURRHOLE WAS CREATED. NO INTERVENTIONS WERE PLANNED OR TAKEN; THE PROCEDURE WAS ABORTED AND THE SURGEON HAD DISCUSSED THE POSSIBILITY OF OPERATING AGAIN IN THE FUTURE. ACCORDING TO THE PATIENT'S NEUROLOGIST, THE PATIENT WAS DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1	00071 YR		Required Intervention