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

Model Number 37612

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0v7nm, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0tkv5, implanted: (b)(6) 2015, product type: lead.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 37642, serial# (b)(4)product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).

Event Description

The manufacturer representative (rep) reported that the patient was having difficulty charging and got two coupling boxes.An antenna locate had not been attempted yet, so the rep would try this with the patient.The rep also noted that the patient was thin and she could feel the implantable neurostimulator (ins) and suspected she could feel the wires on top of the ins.The pocket did not appear deep or the ins tilted.However, no x-ray had been performed to check.There were no associated symptoms.On (b)(6) 2015 the rep further reported that the patient got a maximum of two bars in coupling.They reportedly used the metal detector and it was still no better.The doctor ordered and x-ray of the ins and it showed the ins had flipped.The patient would be scheduled for surgery to flip the ins back.The patient's indications for use were parkinson's dual and movement disorders.No patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

• 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: 5024688
• MDR Text Key: 23826272
• Report Number: 3004209178-2015-16546
• 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: company representative
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Date Device Manufactured: 06/27/2015
• 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): Required Intervention