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

Model Number 7426

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Depression (2361); Neck Stiffness (2434); Ambulation Difficulties (2544)

Event Date 08/05/2009

Event Type  Injury  

Event Description

It was reported that the patient¿s parkinson¿s had been progressing ¿since forever.¿ the patient¿s progressing symptoms included walking stiffness, feeling immobilized, neck stiffness, and depression.The reporter stated that the patient had an x-ray ¿last week¿ to confirm the lead wires were too short.The reporter mentioned that shortly after implant a revision was done to ¿make the leads longer or move the implantable neurostimulator (ins) higher.¿ since then the patient still felt the leads were too short and were tugging on the ins, pulling it higher on her chest.The patient¿s healthcare provider (hcp) told her to ¿just wait and the leads would get longer.¿ the reporter stated that ¿it did not look right,¿ that two wires were visible, sticking out of the patient¿s neck and could be seen under her skin.No erosion was indicated.The reporter noted that the patient¿s symptoms were worse when the ¿wires stuck out, like the stimulation was causing something to happen.¿ the reporter also mentioned that the patient had a mammogram ¿last year¿ and was worried that it crushed a corner of the ins.The corner ¿felt out of place.¿ additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative

Concomitant products: product id 7426, serial# (b)(4), implanted: (b)(6) 2009, product type implantable neurostimulator; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type extension; product id 3387s-40, lot# v252498, implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot# v274380, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type extension.(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: 3845773
• MDR Text Key: 16222945
• Report Number: 3004209178-2014-10053
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2014
• Date Device Manufactured: 04/28/2009
• 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: 00064 YR