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

Model Number 7426

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Low impedance (2285); Device Displays Incorrect Message (2591); Loss of Data (2903)

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

Event Type  Injury  

Event Description

It was reported that there was a power on reset (por).No error code was specified that would have accompanied the por.There were low impedances, 8 ohms.All monopolar and all other bipolar configurations other than 0 and 3 were normal.It was noted that the therapeutic settings were also normal.They were aware of the short circuit.The action required as a result of the event was an explant and replacement, which was completed on (b)(6) 2014.No diagnostic testing or troubleshooting was performed.Following the surgery the patient¿s family was informed that the device was reset to factory settings.They had not noticed any therapeutic deficit due to the device being turned off.The device had been functioning properly a week prior to the date of this report at the pre-operative visit.The patient had been welding after the pre-operative visit for a long period of time.It was noted that they guessed the device was adversely affected by the welding equipment.The patient was alive with no injury.There were no patient symptoms reported.Additional information received reported the manufacturing representative did not recall a message but the device was off and was programmed at 0.0v, 210pw and 30hz.It was unknown how the patient was doing.The patient was receiving effective therapy.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v228940, implanted: (b)(6) 2009, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, 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: 4058710
• MDR Text Key: 4902047
• Report Number: 3004209178-2014-16353
• 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
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2014
• Date Device Manufactured: 03/02/2009
• 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: 00073 YR