MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Coma (2417)

Event Date 04/15/2014

Event Type  Injury  

Event Description

It was reported that after the surgery the patient had been in a state of a coma.It was noted that after the patient regained consciousness the activities of the right lower limb was not flexible.It was noted that there was no patient death.Additional information received reported that the no diagnostics were performed, no malfunctions were seen, and no interventions were taken or planned.It was noted that the patient lived in the hospital now.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0ctzw, implanted: (b)(6) 2014, product type: lead.Product id: 3389s-40, lot# va0cs7a, implanted: (b)(6) 2014, product type: lead.Product id: 37085-60, lot# nkn060779v, implanted: (b)(6) 2014, product type: extension.Product id: 37085-60, lot# nkn060775v, implanted: (b)(6) 2014, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3821544
• MDR Text Key: 20018212
• Report Number: 3004209178-2014-09288
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Device Lot Number: NKM722076H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2014
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 00062 YR