MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problems Low impedance (2285); Low Battery (2584); Battery Problem (2885)

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

Event Type  Injury  

Event Description

It was reported that the patient¿s primary cell devices had depleted and the healthcare professional wanted to switch the patient out to two rechargeable devices.There was an apparent short on combination 1 and 2 which had shown 7 ohms.Therapy impedance was 474 ohms.It was noted that combination 1, 2 was not used in the programming.It was further noted that the patient got almost 100% relief from her dystonia symptoms.Additional information received reported the implantable neurostimulator (ins) with the short had depleted somewhat faster than the other side.It was noted that impedance difference between left and right inss had accounted for that difference.Both inss were explanted and replaced with rechargeable devices on each side.The patient was doing well and receiving therapy.

Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# v700663, implanted: (b)(6) 2011, product type: lead; product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 3387s-40, lot# v475781, implanted: (b)(6) 2010, product type: lead; product id 7482a40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3736519
• MDR Text Key: 15814208
• Report Number: 3004209178-2014-05889
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2014
• Date Device Manufactured: 03/14/2013
• 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
• Patient Age: 00026 YR