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

Model Number 7426

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Pocket Erosion (2013)

Event Type  Injury  

Event Description

It was reported that a short time after implant, while the patient was showering, the implantable neurostimulator (ins) fell out of the pocket right into her hand with blood all over.She was rushed into a second surgery to anchor down the ins and it was sutured down to the chest wall.The patient outcome was not reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # v011075, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Conclusion code and patient codes have been updated.(b)(4).

Event Description

Additional information received from the consumer reported the implant had been "messed up twice." no further information was provided.

• 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: 4755339
• MDR Text Key: 5770975
• Report Number: 3004209178-2015-08619
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Date Device Manufactured: 04/17/2009
• 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