MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7426

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was noted that the patient had bilateral ins systems present during the event.See manufacturer¿s report # 3004209178-2014-15114 for concomitant ins system information.

Event Description

Follow up information received reported that the high impedances were discovered at the physician¿s office appointment (date unknown) and the cause of which were unknown.It was also reported that battery depletion for both of the patient¿s implantable neurostimulator (ins) batteries was normal.The patient was reported as doing fine after the surgery.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

It was reported a couple of months prior to report the patient started to have a shocking sensation down their right side and right arm.The patient had high impedances and they could not isolate it to anything.Both of the patient¿s batteries were near depletion so they replaced both devices in may and everything cleared up, including impedances.

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3387-40, lot# v004947, implanted: (b)(6) 2006, product type: lead.(b)(4).

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 3999542
• MDR Text Key: 4859941
• Report Number: 3004209178-2014-15115
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2007
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2014
• Date Device Manufactured: 05/19/2006
• 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